Abstract 3712: A Randomized Placebo-Controlled Trial of a Conjugate Nicotine Vaccine (NicVAX®) in Smokers Who Want to Quit: 12 Month Results

Background: Cigarette smoking triples the risk of dying from heart disease among middle-aged men and women. A nicotine vaccine (NicVAX®) has been developed to produce nicotine-specific antibodies as a means of reducing entry of nicotine into the brain as an aid to smoking cessation. Objective: To assess 12-month safety, efficacy and immunogenicity of NicVAX in smokers who want to quit. Method: Randomized, double-blinded, placebo-controlled multicenter clinical trial with 2 dose levels of NicVAX (200μg & 400μg) and 2 schedules. Generally healthy adults who smoked ≥ 15 cigarettes/day were recruited. Subjects were randomized 2:1, active:placebo, at 9 sites in the US. The primary endpoint was self reported continuous abstinence for weeks 19 – 26 confirmed by expired CO levels of ≤ 8 ppm. Secondary endpoints include point prevalence abstinence at 12 months. Results: 301 subjects (52% female) with a mean age of 48, smoking on average 24 cigarettes/day were enrolled. A pre-defined analysis of antibody levels for subjects receiving NicVAX were reviewed and divided into low and high responder groups, with the top 30 th percentile representing the high responder group. Analysis for the primary endpoint demonstrated that 15/61 (24.6%) of subjects having the highest antibody titers achieved an 8 week period of continuous abstinence between weeks 19 –26, compared to 13/100 (13.0%) for the subjects who received placebo (p=0.04). In contrast, the quit rate for those subjects that did not achieve a high antibody titer was not significantly different from placebo (14/140, 10%). There was a significant relationship between anti-nicotine antibody levels and continuous abstinence from smoking (p=0.0001). NicVAX was well-tolerated and showed no differences in adverse events or in local/systemic reactions between placebo and each active vaccine group. Conclusion: Proof-of-concept has been established by the strong correlation of high antibody titers with smoking abstinence. Interim data (6 months post vaccination) demonstrate that generating antibodies to nicotine may be a useful approach for aiding smoking cessation. This study will be completed in Sept 2007. Immunogenicity, sustained smoking cessation and relapse rates at 12 months after vaccination will be presented.

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Pharmacist-Delivered Smoking Cessation Program in Community Pharmacy (The FINE Program) in Japan—The Development of a Training Course and a Feasibility Study

Journal of Pharmacy Practice ◽

10.1177/0897190019889745 ◽

2019 ◽

pp. 089719001988974

Author(s):

Mitsuko Onda ◽

Takashi Kuwanoe ◽

Atsunori Hashimoto ◽

Michiko Horiguchi ◽

Masayuki Domichi ◽

...

Keyword(s):

Smoking Cessation ◽

Community Pharmacy ◽

Feasibility Study ◽

Smoking Status ◽

Controlled Trial ◽

Smoking Cessation Program ◽

Community Pharmacies ◽

The Family ◽

Quitting Smoking ◽

Continuous Abstinence

Aim: Although smoking cessation support has been recommended as a routine component of pharmacists’duties, there is limited evidence of smoking cessation being achieved successfully in community pharmacy. The aim of this study was to develop a new smoking cessation program for use in the community pharmacy setting and investigate its feasibility. Methods: A feasibility study (the Family pharmacist’s Intervention for Nicotine Elimination [FINE] program) was conducted using 8 pharmacists at 2 community pharmacies in Japan. The pharmacists recruited as subjects smokers 20 or more years of age who were taking medications such as antidiabetes drugs. The patients completed questionnaires assessing their smoking status, and the pharmacists provided them with smoking cessation support services. Participating patients met with the pharmacists or talked to them on the phone 5 times at 2- to 4-week intervals and received personalized and structured brief smoking cessation advice. The primary outcome was continuous abstinence determined by Micro Smokerlyzer carbon monoxide monitor at 3 months. Results: Of 5306 patients, 2296 patients were screened and the rate of smoking was found to be 12.7%. Five smoking patients received the FINE program from pharmacists who had received training. One of the 5 succeeded in quitting smoking after 3 months. Conclusions: This is the first study to target Japanese smoking patients in community pharmacies with a brief structured intervention. The results tentatively support the feasibility of the FINE program. Further research including a randomized controlled trial is required to confirm the effectiveness of the FINE program.

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Randomized controlled trial of N-acetylcysteine therapy for RYR1-related myopathies

Neurology ◽

10.1212/wnl.0000000000008872 ◽

2020 ◽

Vol 94 (13) ◽

pp. e1434-e1444 ◽

Cited By ~ 5

Author(s):

Joshua J. Todd ◽

Tokunbor A. Lawal ◽

Jessica W. Witherspoon ◽

Irene C. Chrismer ◽

Muslima S. Razaqyar ◽

...

Keyword(s):

Oxidative Stress ◽

Natural History ◽

Least Squares ◽

Primary Endpoint ◽

Controlled Trial ◽

Physical Endurance ◽

Pediatric Dose ◽

6Mwt Distance ◽

Double Blinded ◽

6 Minute Walk Test

ObjectiveTo investigate the efficacy of N-acetylcysteine (NAC) for decreasing elevated oxidative stress and increasing physical endurance in individuals with ryanodine receptor 1-related myopathies (RYR1-RM).MethodsIn this 6-month natural history assessment (n = 37) followed by a randomized, double-blinded, placebo-controlled trial, 33 eligible participants were block-randomized (1:1) to receive NAC (n = 16) or placebo (n = 17), orally for 6 months (adult dose 2,700 mg/d; pediatric dose 30 mg/kg/d). The primary endpoint was urine 15-F2t isoprostane concentration and the clinically meaningful co-primary endpoint was 6-minute walk test (6MWT) distance.ResultsWhen compared to the general population, participants had elevated baseline 15-F2t isoprostane concentrations and most had a decreased 6MWT distance (mean ± SD 3.2 ± 1.5 vs 1.1 ± 1.7 ng/mg creatinine and 468 ± 134 vs 600 ± 58 m, respectively, both p < 0.001). 15-F2t isoprostane concentration and 6MWT distance did not change over the 6-month natural history assessment (p = 0.98 and p = 0.61, respectively). NAC treatment did not improve 15-F2t isoprostane concentration (least squares means difference 0.1 [95% confidence interval [CI] −1.4 to 1.6] ng/mg creatinine, p = 0.88) or 6MWT distance (least squares means difference 24 [95% CI −5.5 to 53.4] m, p = 0.11). NAC was safe and well-tolerated at the doses administered in this study.ConclusionIn ambulatory RYR1-RM–affected individuals, we observed stable disease course, and corroborated preclinical reports of elevated oxidative stress and decreased physical endurance. NAC treatment did not decrease elevated oxidative stress, as measured by 15-F2t isoprostane.Classification of evidenceThis study provides Class I evidence that, for people with RYR1-RM, treatment with oral NAC does not decrease oxidative stress as measured by 15-F2t isoprostane.Clinicaltrials.gov identifierNCT02362425.

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Direct Comparison of Antibody Responses to Four SARS-CoV-2 Vaccines in Mongolia

10.1101/2021.08.22.21262161 ◽

2021 ◽

Author(s):

Naranjargal J. Dashdorj ◽

Oliver F. Wirz ◽

Katharina Roeltgen ◽

Emily Haraguchi ◽

Anthony S. Buzzanco ◽

...

Keyword(s):

Antibody Responses ◽

Health Interventions ◽

High Antibody ◽

Antibody Testing ◽

Public Health Interventions ◽

Vaccine Responses ◽

Blocking Activity ◽

Antibody Titers ◽

Alpha Variant ◽

Antibody Levels

Different vaccines for SARS-CoV-2 are approved in various countries, but few direct comparisons of the antibody responses they stimulate have been reported. We collected plasma specimens in July 2021 from 196 Mongolian participants fully vaccinated with one of four Covid vaccines: Pfizer/BioNTech, AstraZeneca, Sputnik V and Sinopharm. Functional antibody testing with a panel of nine SARS-CoV-2 viral variant RBD proteins reveal marked differences in the vaccine responses, with low antibody levels and RBD-ACE2 blocking activity stimulated by the Sinopharm and Sputnik V vaccines in comparison to the AstraZeneca or Pfizer/BioNTech vaccines. The Alpha variant caused 97% of infections in Mongolia in June and early July 2021. Individuals who recover from SARS-CoV-2 infection after vaccination achieve high antibody titers in most cases. These data suggest that public health interventions such as vaccine boosting, potentially with more potent vaccine types, may be needed to control the COVID-19 pandemic in Mongolia and worldwide.

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POS0600 IMMUNOGENICITY OF RITUXIMAB BIOSIMILAR GP2013: A RARE EVENT, BUT NOT WITHOUT CONSEQUENCES ...

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.954 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 534-535

Author(s):

J. Avouac ◽

R. Cougnaud Murail ◽

C. Goulvestre ◽

S. Dumas ◽

A. Moltó ◽

...

Keyword(s):

Allergic Reaction ◽

Disease Duration ◽

Controlled Trial ◽

Rare Event ◽

Treatment Discontinuation ◽

Severe Allergic Reaction ◽

High Antibody ◽

Entire Treatment Period ◽

Clinical Consequences ◽

Antibody Levels

Background:The bioequivalence between rituximab (RTX) originator and its biosimilar GP2013 has been demonstrated in rheumatoid arthritis (RA) (1). A recent randomized controlled trial suggested in a selected population a very low immunogenicity of GP2013 in RA (<1%) (2).Objectives:To study in daily practice the risk of immunogenicity of patients treated with GP2013 for their chronic inflammatory rheumatic disorder.Methods:Prospective routine care study carried out between September 2018 and August 2020 in the Rheumatology department of Cochin Hospital. We consecutively included patients treated with the biosimilar RTX GP2013, systematically used in the department since March 2018. Samples were taken before each infusion in order to detect anti-RTX antibodies (Ab) and RTX residual concentrations by ELISA (Lisa Tracker Duo Rituximab, LTR005, Theradiag).Results:We included 159 consecutive patients treated with GP2013 (124 women, 78%) with a mean age of 59±13 years and a mean disease duration of 18±11 years. Among these 159 patients, 108 (68%) had RA and 51 had another disease (16 systemic sclerosis (SSc), 15 mixed connective tissue disease (MCTD), 5 systemic lupus (SLE), 5 inflammatory myopathies (MI), 5 undifferentiated polyarthritis, 2 juvenile idiopathic arthritis (JIA) and 3 primary Sjögren’s syndromes). 137 patients (86%) were receiving associated disease-modifying therapy (DMARD), mainly methotrexate (111/137 patients, 81%). 120 patients (75%) were in maintenance therapy with originator RTX (cumulative dose of RTX: 3.5±6g) before the switch to GP2013 in March 2018. Originator RTX was not re-established during the entire treatment period. The other 39 patients (25%) treated with GP2013 were naïve of originator RTX.The analysis of the first sample, performed before the second GP2013 infusion, identified 8 patients (5 RA, 1 SLE, 1 MCTD and 1 SSc) with positive anti-RTX antibodies (prevalence 5%), with rates varying between 6 and >100ng/mL and undetectable residual RTX concentrations. Among these 8 patients, 6 had previously received originator RTX and 2 were RTX-naïve patients. There was a trend for higher body mass index in patients with positive anti-RTX antibodies (28±7 vs. 25±6 kg/m2, p=0.12), and no association was observed between anti-RTX immunization and age, disease duration, combination with conventional DMARD, mean interval between infusions or cumulative RTX dose.Among the 8 immunized patients, two groups could be isolated: i) a group of 5 patients (3 RA, 1 SLE, 1 SSc) with low antibody levels (6-22 ng/mL) and no significant clinical consequences (absence of treatment discontinuation and loss of efficacy after 13±4 months of follow-up, only one minor allergic reaction) and ii) a group of 3 patients (2 RA, 1 MCTD) with a high antibody levels (≥100ng/mL) and meaningful clinical consequences: one severe allergic reaction during the second GP2013 infusion leading to treatment discontinuation, and a loss of efficacy with incomplete B depletion in 2 patients leading to RTX dose escalation from 500 mg to 1 g. Among the 151 patients not immunized at the time of the first sample, no severe allergic reaction and 6 minor allergic reactions were noted under GP2013.Conclusion:The immunogenicity of patients treated with RTX is a rare event with possible clinical and biological consequences, especially in patients with high antibody levels.References:[1]Smolen et al, Ann Rheum Dis 2017[2]Tony et al, Arthritis Care Res 2019Disclosure of Interests:None declared

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A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.12252 ◽

2018 ◽

Cited By ~ 1

Author(s):

Akihiro Nomura ◽

Hiroki Tateno ◽

Katsunori Masaki ◽

Tomoyasu Muto ◽

Shin Suzuki ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Nicotine Dependence ◽

Controlled Trial ◽

Smartphone App ◽

Smoking Cessation Treatment ◽

Randomized Controlled ◽

Cessation Treatment ◽

Co Concentration ◽

Continuous Abstinence

BACKGROUND Smoking cessation treatment programs have been widely available for patients with nicotine dependence. Despite intensive programs, the continuous abstinence rate (CAR) from weeks 9-12 is still about 50%. Recently, a smartphone app emerged as a novel tool for therapeutic interventions, including nicotine dependence. In this study, we developed “CureApp Smoking Cessation” (CASC), which consists of a smartphone app for patients and a Web-based patient management software for doctors with a mobile carbon monoxide (CO) checking device to improve the efficacy of the smoking cessation treatment. OBJECTIVE This study aims to evaluate whether the CASC app is effective for individuals with nicotine dependence in addition to standard smoking cessation programs. METHODS This will be a randomized, sham-controlled, open-label, multicenter trial. We will recruit participants with nicotine dependence, but are otherwise healthy adults. We will randomize and allocate participants 1:1 to the CASC treatment group or a control app group. Both groups will receive a 12-week standard smoking cessation program with pharmacotherapy and counseling. In addition, participants in the treatment group will have the CASC app installed on their smartphone, which will provide video tutorials, advice from an artificial intelligence nurse, a digital diary, and measure daily exhaled CO concentration. In contrast, the control group will have the control app installed on their smartphone, where all the functions that can potentially effect smoking cessation are removed. The primary outcome will be the biochemically validated CAR from weeks 9-24. The success of smoking cessation will be defined as self-reported continuous abstinence from weeks 9-24 and exhaled CO concentration ≤10 ppm both at weeks 12 and 24. The main secondary outcomes will be the CAR from weeks 9-12, weeks 9-52, and 7-day point prevalence abstinence at weeks 4, 8, 12, 24, and 52. RESULTS We will recruit 580 participants with nicotine dependence from October 2017 to September 2018 or until the recruitment process is complete. The final 52-week follow-up will be completed in October 2019. We expect all trial results to be available by the end of 2019. The trial is funded by CureApp, Inc. CONCLUSIONS This is the first randomized controlled trial to evaluate the efficacy of CASC. We expect that CASC, in addition to standard smoking cessation programs, has a significantly higher CAR during weeks 9-24 than the control app. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry UMIN000031589; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033555 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12252

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Comparing the Efficacy of an Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging Versus Email: Randomized Controlled Trial (Preprint)

10.2196/preprints.12137 ◽

2018 ◽

Author(s):

Inger Torhild Gram ◽

Dillys Larbi ◽

Silje Camilla Wangberg

Keyword(s):

Smoking Cessation ◽

Text Messaging ◽

Controlled Trial ◽

Text Message ◽

Population Level ◽

Randomized Controlled ◽

Cessation Intervention ◽

Double Blinded ◽

Time Point

BACKGROUND There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone–based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. OBJECTIVE This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. METHODS We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. RESULTS At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (<italic>P</italic>=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. CONCLUSIONS This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. CLINICALTRIAL ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427

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Comparing the Efficacy of an Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging Versus Email: Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/12137 ◽

2019 ◽

Vol 7 (9) ◽

pp. e12137 ◽

Cited By ~ 6

Author(s):

Inger Torhild Gram ◽

Dillys Larbi ◽

Silje Camilla Wangberg

Keyword(s):

Smoking Cessation ◽

Text Messaging ◽

Controlled Trial ◽

Text Message ◽

Population Level ◽

Randomized Controlled ◽

Cessation Intervention ◽

Double Blinded ◽

Time Point

Background There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone–based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. Objective This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. Methods We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. Results At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. Conclusions This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. Trial Registration ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427

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Heterologous protection against malaria by a simple chemoattenuated PfSPZ vaccine regimen in a randomized trial

Nature Communications ◽

10.1038/s41467-021-22740-w ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Zita Sulyok ◽

Rolf Fendel ◽

Bianca Eder ◽

Freia-Raphaella Lorenz ◽

Natasha KC ◽

...

Keyword(s):

Malaria Infection ◽

Controlled Trial ◽

Protein Microarray ◽

Risk Difference ◽

Vaccine Regimen ◽

Primary Endpoints ◽

Controlled Human Malaria Infection ◽

Double Blinded ◽

Antibody Levels ◽

Heterologous Protection

AbstractImmunization with Plasmodium falciparum (Pf) sporozoites under chemoprophylaxis (PfSPZ-CVac) is the most efficacious approach to malaria vaccination. Implementation is hampered by a complex chemoprophylaxis regimen and missing evidence for efficacy against heterologous infection. We report the results of a double-blinded, randomized, placebo-controlled trial of a simplified, condensed immunization regimen in malaria-naive volunteers (EudraCT-Nr: 2018-004523-36). Participants are immunized by direct venous inoculation of 1.1 × 105 aseptic, purified, cryopreserved PfSPZ (PfSPZ Challenge) of the PfNF54 strain or normal saline (placebo) on days 1, 6 and 29, with simultaneous oral administration of 10 mg/kg chloroquine base. Primary endpoints are vaccine efficacy tested by controlled human malaria infection (CHMI) using the highly divergent, heterologous strain Pf7G8 and safety. Twelve weeks following immunization, 10/13 participants in the vaccine group are sterilely protected against heterologous CHMI, while (5/5) participants receiving placebo develop parasitemia (risk difference: 77%, p = 0.004, Boschloo’s test). Immunization is well tolerated with self-limiting grade 1–2 headaches, pyrexia and fatigue that diminish with each vaccination. Immunization induces 18-fold higher anti-Pf circumsporozoite protein (PfCSP) antibody levels in protected than in unprotected vaccinees (p = 0.028). In addition anti-PfMSP2 antibodies are strongly protection-associated by protein microarray assessment. This PfSPZ-CVac regimen is highly efficacious, simple, safe, well tolerated and highly immunogenic.

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Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial (Preprint)

10.2196/preprints.10893 ◽

2018 ◽

Author(s):

Neill Bruce Baskerville ◽

Laura Louise Struik ◽

Godefroy Emmanuel Guindon ◽

Cameron D Norman ◽

Robyn Whittaker ◽

...

Keyword(s):

Smoking Cessation ◽

Young Adults ◽

Young Adult ◽

Mobile Technology ◽

Controlled Trial ◽

Randomized Controlled ◽

Quit Smoking ◽

Self Help ◽

Continuous Abstinence

BACKGROUND Digital mobile technology presents a promising medium for reaching young adults with smoking cessation interventions because they are the heaviest users of this technology. OBJECTIVE The aim of this study was to determine the efficacy of an evidence-informed smartphone app for smoking cessation, Crush the Crave (CTC), on reducing smoking prevalence among young adult smokers in comparison with an evidence-informed self-help guide, On the Road to Quitting (OnRQ). METHODS A parallel, double-blind, randomized controlled trial with 2 arms was conducted in Canada to evaluate CTC. In total, 1599 young adult smokers (aged 19 to 29 years) intending to quit smoking in the next 30 days were recruited online and randomized to receive CTC or the control condition OnRQ for a period of 6 months. The primary outcome measure was self-reported continuous abstinence at the 6-month follow-up. RESULTS Overall follow-up rates were 57.41% (918/1599) and 60.48% (967/1599) at 3 and 6 months, respectively. Moreover, 45.34% (725/1599) of participants completed baseline, 3-, and 6-month follow-up. Intention-to-treat analysis (last observation carried forward) showed that continuous abstinence (N=1599) at 6 months was not significantly different at 7.8% (64/820) for CTC versus 9.2% (72/779) for OnRQ (odds ratio; OR 0.83, 95% CI 0.59-1.18). Similarly, 30-day point prevalence abstinence at 6 months was not significantly different at 14.4% (118/820) and 16.9% (132/779) for CTC and OnRQ, respectively (OR 0.82, 95% CI 0.63-1.08). However, these rates of abstinence were favorable compared with unassisted 30-day quit rates of 11.5% among young adults. Secondary measures of quit attempts and the number of cigarettes smoked per day at 6-month follow-up did not reveal any significant differences between groups. For those who completed the 6-month follow-up, 85.1% (359/422) of young adult smokers downloaded CTC as compared with 81.8% (346/423) of OnRQ, χ21(N=845)=1.6, P=.23. Furthermore, OnRQ participants reported significantly higher levels of overall satisfaction (mean 3.3 [SD 1.1] vs mean 2.6 [SD 1.3]; t644=6.87, P<.001), perceived helpfulness (mean 5.8 [SD 2.4] vs mean 4.3 [SD 2.6], t657=8.0, P<.001), and frequency of use (mean 3.6 [SD 1.2] vs mean 3.2 [SD 1.1], t683=5.7, P<.001) compared with CTC participants. CONCLUSIONS CTC was feasible for delivering cessation support but was not superior to a self-help guide in helping motivated young adults to quit smoking. CTC will benefit from further formative research to address satisfaction and usage. As smartphone apps may not serve as useful alternatives to printed self-help guides, there is a need to conduct further research to understand how digital mobile technology smoking cessation interventions for smoking cessation can be improved. CLINICALTRIAL ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i)

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HOMOLOGOUS IMMUNOLOGICAL STUDIES OF OCULAR LENS

Journal of Experimental Medicine ◽

10.1084/jem.105.5.453 ◽

1957 ◽

Vol 105 (5) ◽

pp. 453-462 ◽

Cited By ~ 22

Author(s):

S. P. Halbert ◽

D. Locatcher-Khorazo ◽

L. Swick ◽

R. Witmer ◽

B. Seegal ◽

...

Keyword(s):

Anterior Chamber ◽

Small Group ◽

Human Lens ◽

Adult Rabbit ◽

High Antibody ◽

Ocular Lens ◽

Antibody Titers ◽

Rabbit Lens ◽

Antibody Levels

Lenses of rabbits with high titers of homologous lens antibodies showed no lesions, even after repeated paracentesis of the anterior chamber in a number of such animals. In these instances, lens antibodies were shown to be present in both the primary and secondary aqueous humors. A small group of rabbits with high homologous anti-lens antibody titers were successfully bred. These had been immunized with adult rabbit lens pools in Freund's adjuvants, and had high antibody levels throughout pregnancy. No significant congenital lens lesions were found when these 18 young from 3 litters were compared with the 17 young from 3 litters of mothers who had no detectable anti-lens antibody through gestation. The latter group of does had received the equivalent doses of homologous lens in saline. Patients with cataract did not show demonstrable anti-lens antibodies in their serum when tested by the agar precipitin technic against cataractous human lens homogenates.

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