scholarly journals Safety and Immunogenicity of CpG 1018 and Aluminium Hydroxide-Adjuvanted SARS-CoV-2 S-2P Protein Vaccine MVC-COV1901: A Large-Scale Double-Blinded, Randomised, Placebo-Controlled Phase 2 Trial

2021 ◽  
Author(s):  
Szu-Min Hsieh ◽  
Ming-Che Liu ◽  
Yen-Hsu Chen ◽  
Wen-Sen Lee ◽  
Shinn-Jang Hwang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Aluminium Hydroxide ◽  
Large Scale ◽  
Geometric Mean ◽  
Phase 2 ◽  
Protein Vaccine ◽  
Multi Centre Study ◽  
Phase 2 Trial ◽  
Double Blinded ◽  
Study Participants

Background We have assessed the safety and immunogenicity of MVC-COV1901, a recombinant protein vaccine containing prefusion-stabilized spike protein S-2P adjuvanted with CpG 1018 and aluminium hydroxide against COVID-19. Methods This is a phase 2, prospective, double-blinded, placebo-controlled, and multi-centre study to evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 vaccine candidate MVC-COV1901. The study comprised 3,844 participants of ≥ 20 years who were generally healthy or with stable pre-existing medical conditions. The study participants were randomly assigned in a 6:1 ratio to receive either MVC-COV1901 containing 15 mcg of S-2P protein or placebo containing saline. Participants received two doses of MVC-COV1901 or placebo, administered 28 days apart via intramuscular injection. The primary outcomes were to evaluate the safety, tolerability, and immunogenicity of MVC-COV1901 from Day 1 (the day of first vaccination) to Day 57 (28 days after the second dose). Immunogenicity of MVC-COV1901 was assessed through geometric mean titres (GMT) and seroconversion rates (SCR) of neutralising antibody and antigen-specific immunoglobulin. This clinical trial is registered at ClinicalTrials.gov: NCT04695652. Findings From the start of this phase 2 trial to the time of interim analysis, no vaccine-related Serious Adverse Events (SAEs) was recorded. The most common solicited adverse events across all study participants were pain at the injection site (64%), and malaise/fatigue (35%). Fever was rarely reported (<1%). For all participants in the MVC-COV1901 group, at 28 days after the second dose against wild type SARS-CoV-2 virus, the GMT was 662.3 (408 IU/mL), the GMT ratio was 163.2, and the seroconversion rate was 99.8%. Interpretation MVC-COV1901 shows good safety profiles and promising immunogenicity responses. The current data supports MVC-COV1901 to enter phase 3 efficacy trials, and could enable regulatory considerations for Emergency Use Authorisation (EUA). Funding Medigen Vaccine Biologics Corporation and Taiwan Centres for Disease Control.

scholarly journals Randomized, Double-Blinded, Phase 2 Trial of WR 279,396 (Paromomycin and Gentamicin) for Cutaneous Leishmaniasis in Panama

2013 ◽  
Vol 89 (3) ◽  
pp. 557-563 ◽  
Author(s):  
Néstor Sosa ◽  
Zeuz Capitán ◽  
Javier Nieto ◽  
Melissa Nieto ◽  
José Calzada ◽  
...  
Keyword(s):  
Cutaneous Leishmaniasis ◽  
Phase 2 ◽  
Phase 2 Trial ◽  
Double Blinded

scholarly journals Immunogenicity and safety of a third dose, and immune persistence of CoronaVac vaccine in healthy adults aged 18-59 years: interim results from a double-blind, randomized, placebo-controlled phase 2 clinical trial

2021 ◽  
Author(s):  
Hongxing Pan ◽  
Qianhui Wu ◽  
Gang Zeng ◽  
Juan Yang ◽  
Deyu Jiang ◽  
...  
Keyword(s):  
Large Scale ◽  
Dose Group ◽  
Geometric Mean ◽  
Development Program ◽  
Neutralizing Antibody ◽  
Immune Memory ◽  
High Dose ◽  
Phase 2 ◽  
Serious Adverse Events ◽  
Double Blind

Background Large-scale vaccination is being implemented globally with CoronaVac, an inactivated vaccine against coronavirus disease 2019 (COVID-19). Immunogenicity and safety profiles of homologous two-dose schedules have been published. We report interim results of immune persistence, and the immunogenicity and safety of a third dose of CoronaVac. Methods In this ongoing, placebo-controlled, double-blind phase 2 trial in 18-to-59-year-olds, we randomly assigned subjects, 1:1:1:1, to one of four schedules to receive a third dose, 28 days or 6 months after two two-dose regimens (14-day or 28-day apart): schedule 1: days 0, 14, 42; schedule 2: days 0, 14, 194; schedule 3: days 0, 28, 56; schedule 4: days 0, 28, 208. For each schedule, participants were randomly assigned to either a medium-dose group (3 μg per 0.5 mL of aluminum hydroxide diluent per dose), a high-dose group (6 μg), or a placebo group (2:2:1). The primary outcome was geometric mean titers (GMTs) of neutralizing antibody to live SARS-CoV-2. Results Overall, 540 participants received a third dose. In the 3 μg group, neutralizing antibody titers induced by the first two doses declined after 6-8 months to below the seropositive cutoff (GMT: 4.1 [95%CI 3.3-5.2] for Schedule 2 and 6.7 [95%CI 5.2-8.6] for Schedule 4). When a third dose was given 6-8 months after a second dose, GMTs assessed 14 days later increased to 137.9 [95%CI 99.9-190.4] for Schedule 2, and 143.1 [95%CI 110.8-184.7] for Schedule 4, approximately 3-fold above Schedule 1 and Schedule 3 GMTs after third doses. Similar patterns were observed for the 6 μg group. The severity of solicited local and systemic adverse reactions reported within 28 days after the third dose were grade 1 to grade 2 in all vaccination cohorts. None of the fourteen serious adverse events were considered to be related to vaccination. Conclusions A third dose of CoronaVac administered 6 or more months after a second dose effectively recalled specific immune response to SARS-CoV-2, resulting in a remarkable increase in antibody levels, and indicating that a two-dose schedule generates good immune memory. Optimizing the timing of a booster dose should take into account immunogenicity, vaccine efficacy/effectiveness, local epidemic situation, infection risk, and vaccine supply. (Funded by the National Key Research and Development Program, Beijing Science and Technology Program and National Science Fund for Distinguished Young Scholars; ClinicalTrials.gov number, NCT04352608.)

scholarly journals A nonrandomized phase 2 trial of oral thymic peptides in hospitalized patients with Covid-19

2021 ◽  
Author(s):  
Héctor M. Ramos-Zaldívar ◽  
Karla G. Reyes-Perdomo ◽  
Nelson A. Espinoza-Moreno ◽  
Ernesto Tomás Dox-Cruz ◽  
Thania Camila Aguirre Urbina ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Standard Care ◽  
Registry Data ◽  
Control Group ◽  
Phase 2 ◽  
Safety And Efficacy ◽  
Link Type ◽  
Phase 2 Trial ◽  
Thymic Peptides

AbstractBackgroundCoronavirus disease 2019 (Covid-19) active cases continue to demand the development of safe and effective treatments. This is the first clinical trial to evaluate the safety and efficacy of oral thymic peptides.MethodsWe conducted a nonrandomized phase 2 trial with a historic control group to evaluate the safety and efficacy of a daily 250-mg oral dose of thymic peptides in the treatment of hospitalized Covid-19 patients. Comparison based on standard care from registry data was performed after propensity score matching. The primary outcomes were survival, time to recovery and the number of participants with treatment-related adverse events or side effects by day 20.ResultsA total of 44 patients were analyzed in this study, 22 in the thymic peptides group and 22 in the standard care group. There were no deaths in the intervention group, compared to 24% mortality in standard care by day 20 (log-rank P=0.02). The Kaplan-Meier analysis showed a significantly shorter time to recovery by day 20 in the thymic peptides group as compared with standard care (median, 6 days vs. 12 days; hazard ratio for recovery, 2.75 [95% confidence interval, 1.34 to 5.62]; log-rank P=0.002). No side effects or adverse events were reported.ConclusionIn patients hospitalized with Covid-19, the use of thymic peptides reported no side effects, adverse events, or deaths by day 20. When compared with registry data, a significantly shorter time to recovery and mortality reduction was measured. The Catholic University of Honduras Medical Research Group (GIMUNICAH) is working on a more extensive phase 3 trial.Trial registrationClinicalTrials.govNCT04771013. February 25, 2021.

scholarly journals Randomized, placebo controlled, double blinded pilot superiority phase 2 trial to evaluate the effect of curcumin in moderate to severe asthmatics

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Michele Quan ◽  
Abdullah Alismail ◽  
Noha Daher ◽  
Derrick Cleland ◽  
Sonia Chavan ◽  
...  
Keyword(s):  
Asthma Control ◽  
Clinic Visit ◽  
Phone Call ◽  
Blood Eosinophil ◽  
Therapeutic Effects ◽  
Phase 2 ◽  
Asthma Control Test ◽  
Phase 2 Trial ◽  
Double Blinded ◽  
Clinic Visits

Abstract Background Curcumin, a derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions (e.g., anorexia and arthritis) because of its well-established anti-inflammatory properties. Studies have shown that the use of curcumin in mice models has led to reduction in several inflammatory markers as well as key inflammatory pathway enzymes. As a result, studies in Western medicine have developed to determine if this recognized benefit can be utilized for patients with inflammatory lung diseases, such as asthma. This study will seek to better understand if curcumin can be used as an adjunctive therapy for improving asthma control of patients with moderate to severe asthma; a finding we hope will allow for a more affordable treatment. Methods This study will utilize a randomized, placebo controlled, double blinded pilot superiority phase 2 trial at an outpatient pulmonary clinic in Southern California, USA. Subjects will be receiving Curcumin 1500 mg or matching placebo by mouth twice daily for the study period of 12 weeks. Subjects will be randomized to either a placebo or intervention Curcumin. Subjects will have 6 clinic visits: screening visit, a baseline visit, monthly clinic visits (weeks 4, 8, and 12), at weeks 4, 8, and a follow-up clinic visit or phone-call (week 16). Changes in asthma control test scores, number of days missed from school/work, FEV1 (% predicted), FEV1/FVC ratio, FVC (% predicted), blood eosinophil count, blood total IgE, and FeNO levels will be compared by group over time. Discussion The therapeutic effects of curcumin have been studied on a limited basis in asthmatics and has shown mixed results thus far. Our study hopes to further establish the benefits of curcumin, however, there are potential issues that may arise from our study design that we will address within this paper. Moreover, the onset of the COVID-19 pandemic has resulted in safety concerns that have delayed initiation of our study. This study will contribute to existing literature on curcumin’s role in reducing lung inflammation as it presents in asthmatics as well as patients suffering from COVID-19. Trial registration This study protocol has been approved by the Institutional Review Board at Loma Linda University Health, (NCT04353310). IND# 145101 Registered April 20th, 2020. https://clinicaltrials.gov/ct2/show/NCT04353310.

scholarly journals Safety and Immunogenicity of a Second Dose of an Investigational Maternal Trivalent Group B Streptococcus Vaccine in Nonpregnant Women 4–6 Years After a First Dose: Results From a Phase 2 Trial

2019 ◽  
Vol 70 (12) ◽  
pp. 2570-2579 ◽  
Author(s):  
Geert Leroux-Roels ◽  
Zourab Bebia ◽  
Cathy Maes ◽  
Annelies Aerssens ◽  
Fien De Boever ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Geometric Mean ◽  
Group B Streptococcus ◽  
Vaccine Dose ◽  
Phase 2 ◽  
Multiplex Immunoassay ◽  
Maternal Immunization ◽  
Phase 2 Trial ◽  
Group B ◽  
Favorable Safety

Abstract Background Maternal immunization against group B streptococcus (GBS) could protect infants from invasive GBS disease. Additional doses in subsequent pregnancies may be needed. We evaluated the safety and immunogenicity of a second dose of an investigational trivalent CRM197-glycoconjugate GBS vaccine (targeting serotypes Ia/Ib/III), administered to nonpregnant women 4–6 years postdose 1. Methods Healthy women either previously vaccinated with 1 dose of trivalent GBS vaccine 4–6 years before enrollment (n = 53) or never GBS vaccinated (n = 27) received a single trivalent GBS vaccine injection. Adverse events (AEs) were recorded. Serotype-specific (Ia/Ib/III) anti-GBS antibodies were measured by multiplex immunoassay prevaccination and 30/60 days postvaccination. Results AEs were reported with similar rates after a first or second dose; none were serious. Of previously GBS-vaccinated women, 92%–98% had anti-GBS concentrations that exceeded an arbitrary threshold (8 µg/mL) for each serotype 60 days postdose 2 vs 36%–56% postdose 1 in previously non–GBS-vaccinated women. Of previously GBS-vaccinated women with undetectable baseline (predose 1) anti-GBS levels, 90%–98% reached this threshold postdose 2. For each serotype, anti-GBS geometric mean concentrations (GMCs) 30/60 days postdose 2 in previously GBS-vaccinated women were ≥200-fold higher than baseline GMCs. Among women with undetectable baseline anti-GBS levels, postdose 2 GMCs in previously GBS-vaccinated women exceeded postdose 1 GMCs in previously non–GBS-vaccinated women (≥7-fold). Conclusions A second trivalent GBS vaccine dose administered 4–6 years postdose 1 was immunogenic with a favorable safety profile. Women with undetectable preexisting anti-GBS concentrations may benefit from a sufficiently spaced second vaccine dose. Clinical Trials Registration NCT02690181

scholarly journals Extended Safety, Immunogenicity and Efficacy of a Blood-Stage Malaria Vaccine in Malian Children: 24-Month Follow-Up of a Randomized, Double-Blinded Phase 2 Trial

PLoS ONE ◽  
2013 ◽  
Vol 8 (11) ◽  
pp. e79323 ◽  
Author(s):  
Matthew B. Laurens ◽  
Mahamadou A. Thera ◽  
Drissa Coulibaly ◽  
Amed Ouattara ◽  
Abdoulaye K. Kone ◽  
...  
Keyword(s):  
Malaria Vaccine ◽  
Blood Stage ◽  
Phase 2 ◽  
Phase 2 Trial ◽  
Double Blinded ◽  
Blood Stage Malaria

scholarly journals Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non‐responders: double‐blinded, randomised, controlled phase 2 trial

2021 ◽  
Author(s):  
Özgür Muhammet Koc ◽  
Philippe De Smedt ◽  
Cécile Kremer ◽  
Geert Robaeys ◽  
Pierre Van Damme ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Hepatitis B Vaccine ◽  
Phase 2 ◽  
Phase 2 Trial ◽  
Randomised Controlled ◽  
Double Blinded
Sign in / Sign up

Export Citation Format

Share Document