scholarly journals Immune Memory Response After a Booster Injection of mRNA-1273 for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)

2021 ◽  
Author(s):  
Laurence Chu ◽  
David Montefiori ◽  
Wenmei Huang ◽  
Biliana Nestorova ◽  
Ying Chang ◽  
...  
Keyword(s):  
Neutralizing Antibody ◽  
Primary Vaccination ◽  
Immune Memory ◽  
Serious Adverse Events ◽  
Booster Injection ◽  
Memory Response ◽  
Primary Series ◽  
The One ◽  
Study Participants ◽  
Antibody Levels

Rising breakthrough infections of coronavirus-2 (SARS-CoV-2) in previously immunized individuals has raised concerns for a potential booster to combat suspected waning immunity and new variants. In this study, participants immunized 6-8 months earlier with a primary series of two doses of 50 or 100 μg of mRNA-1273 were administered a booster injection of 50 μg of mRNA-1273. Neutralizing antibody levels at one month after the booster were 1.7-fold higher than those one-month post primary series second injection meeting the prespecified criteria for noninferiority, and indicating an immune memory response. The reactogenicity after the booster dose was similar to that after the second dose in the primary series of two doses of mRNA-1273 (50 or 100 μg) with no serious adverse events reported in the one-month follow-up period. These results demonstrate that a booster injection of mRNA-1273 in previously immunized individuals stimulated an immune response greater than the primary vaccination series.

Persistence of Antibodies to 2 Virus-Like Particle Norovirus Vaccine Candidate Formulations in Healthy Adults: 1-Year Follow-up With Memory Probe Vaccination

2019 ◽  
Vol 220 (4) ◽  
pp. 603-614 ◽  
Author(s):  
Robert L Atmar ◽  
Frank Baehner ◽  
Jakob P Cramer ◽  
Eric Lloyd ◽  
James Sherwood ◽  
...  
Keyword(s):  
Vaccine Candidate ◽  
Immunoglobulin A ◽  
Primary Vaccination ◽  
Immune Memory ◽  
Virus Like Particle ◽  
Memory Probe ◽  
Antibody Titers ◽  
Antibody Levels ◽  
With Memory

AbstractBackgroundWe previously reported the tolerability and immunogenicity 1 month after intramuscular administration of 2 bivalent virus-like particle (VLP)–based candidate norovirus vaccine formulations in adults. We now describe the persistence of immunity and responses to a memory probe vaccination 1 year later.MethodsA total of 454 healthy men and women aged 18–49 years in 3 equal groups received placebo (saline) or 15/50 or 50/50 vaccine formulations (ie, 15 or 50 µg of GI.1 genotype VLPs, respectively, and 50 µg of GII.4c VLPs) with MPL and Al(OH)3. Immunogenicity and safety were assessed up to day 365, when 351 participants received a memory probe vaccination of 15 µg each of GI.1 and GII.4c VLPs with Al(OH)3.ResultsNo safety signals were detected up to 1 year after the first vaccination. Pan-immunoglobulin, immunoglobulin A, and histo-blood group antigen–blocking (HBGA) antibody levels among vaccinees waned but remained higher than levels before vaccination and levels in placebo recipients on days 180 and 365. Memory probe vaccination increased all antibody titers. Levels of HBGA antibodies to GI.1 but not GII.4c were higher after the first vaccination in candidate vaccine groups, compared with those in the placebo group.ConclusionLevels of antibodies to both candidate norovirus VLP formulations persisted above baseline levels for at least 1 year after primary vaccination. HBGA-blocking responses to the memory probe for GI.1 but not GII.4c displayed characteristics of immune memory.Clinical Trials RegistrationNCT02142504.

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 Durability of antibody responses elicited by a single dose of Ad26.COV2.S and substantial increase following late boosting

2021 ◽  
Author(s):  
Jerald Sadoff ◽  
Mathieu Le Gars ◽  
Vicky Cardenas ◽  
Georgi Shukarev ◽  
Nathalie Vaissiere ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Booster Dose ◽  
Age Groups ◽  
Neutralizing Antibody ◽  
Primary Vaccination ◽  
Antibody Responses ◽  
Binding Antibody ◽  
Antibody Levels ◽  
The Impact

AbstractBackgroundWe evaluated the durability of SARS-CoV-2 antibody levels elicited by the single dose Janssen COVID-19 vaccine, Ad26.COV2.S, and the impact on antibody responses of boosting with Ad26.COV2.S after 6 months in clinical trial participants.MethodsSpike-binding antibody and SARS-CoV-2 neutralizing antibody levels elicited by a single-dose Ad26.COV2.S (5×1010 viral particles [vp]) primary regimen and booster doses (5×1010 vp and 1.25×1010 vp) were assessed by ELISA and wild-type VNA in sera from participants in a Phase 1/2a clinical trial (Cohort 1a, 18–55 years old, N=25; Cohort 2a, 18–55 years old boosted at 6 months, N=17; Cohort 3, ≥65 years old, N=22) and a Phase 2 clinical trial (18–55 and ≥65-year old participants boosted at 6 months, total N=73). Neutralizing antibody levels were determined approximately 8 months after the primary vaccination in participants aged 18–55 years and approximately 9 months in participants aged ≥65 years. Binding antibody levels were evaluated 6 months after primary vaccination and 7- and 28-days after booster doses in both age groups.ResultsA single dose of Ad26.COV2.S elicited neutralizing antibodies that remained largely stable for approximately 8–9 months and binding antibodies that remained stable for at least 6 months irrespective of age group. A 5×1010 vp booster dose at 6 months post prime vaccination in 18–55-year-old adults elicited a steep and robust 9-fold increase at Day 7 post boost compared to Day 29 levels following the initial immunization. A lower booster dose of 1.25×1010 vp at 6 months in adults 18–55 and ≥65 years of age also elicited a rapid and high increase of 6–7.7 fold at Day 28 post boost compared to Day 29 levels following the initial immunization, with similar magnitude of post-boost responses in both age groups.ConclusionsA single dose of Ad26.COV2.S, which demonstrated protection in a Phase 3 efficacy trial, elicited durable neutralizing and binding antibodies for at least 8 and 6 months, respectively, in adults >18 years of age at levels similar to Day 29 responses. A 5×1010 vp or 1.25×1010 vp booster dose at 6 months elicited rapid and robust increases in spike binding antibody levels. The anamnestic responses after booster immunization imply robust immune memory elicited by single-dose Ad26.COV2.S.

scholarly journals Robust Neutralizing Antibody Levels Detected after Either SARS-CoV-2 Vaccination or One Year after Infection

Viruses ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2003
Author(s):  
Stefan Glöckner ◽  
Franziska Hornung ◽  
Michael Baier ◽  
Sebastian Weis ◽  
Mathias W. Pletz ◽  
...  
Keyword(s):  
Neutralizing Antibodies ◽  
Booster Vaccination ◽  
Neutralizing Antibody ◽  
Neutralization Assay ◽  
Neutralization Titer ◽  
Neutralization Capacity ◽  
A Cell ◽  
One Year ◽  
Study Participants ◽  
Antibody Levels

Humoral immunity after infection or after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been attributed a key part in mitigating the further transmission of the virus. In this study, we used a commercial anti-Spike immunoglobulin G (S-IgG) assay and developed a cell culture-based neutralization assay to understand the longitudinal course of neutralizing antibodies in both SARS-CoV2 infected or vaccinated individuals. We show that even more than one year after infection, about 78% of observed study participants remained seropositive concerning S-IgG antibodies. In addition, the serum of the individuals had stable neutralization capacity in a neutralization assay against a SARS-CoV-2 patient isolate from March 2020. We also examined volunteers after either homologous BNT162b2 prime-boost vaccination or heterologous AZD1222 prime/mRNA-based booster vaccination. Both the heterologous and the homologous vaccination regimens induced higher levels of neutralizing antibodies in healthy subjects when compared to subjects after a mild infection, showing the high effectiveness of available vaccines. In addition, we could demonstrate the reliability of S-IgG levels in predicting neutralization capacity, with 94.8% of seropositive samples showing a neutralization titer of ≥10, making it a viable yet cheap and easy-to-determine surrogate parameter for neutralization capacity.

scholarly journals Variant SARS-CoV-2 mRNA vaccines confer broad neutralization as primary or booster series in mice

2021 ◽  
Author(s):  
Kai Wu ◽  
Angela Choi ◽  
Matthew Koch ◽  
Sayda Elbashir ◽  
LingZhi Ma ◽  
...  
Keyword(s):  
Phase 1 ◽  
Neutralizing Antibody ◽  
Primary Vaccination ◽  
Viral Escape ◽  
Phase 3 ◽  
S Protein ◽  
Global Pandemic ◽  
Primary Series ◽  
Antibody Titers ◽  
Induced Immunity

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of a global pandemic that has led to more than 2.8 million deaths worldwide. Safe and effective vaccines are now available, including Moderna's COVID-19 vaccine (mRNA-1273) that showed 94% efficacy in prevention of symptomatic COVID-19 disease in a phase 3 clinical study. mRNA-1273 encodes for a prefusion stabilized full length spike (S) protein of the Wuhan-Hu-1 isolate. However, the emergence of SARS-CoV-2 variants has led to concerns of viral escape from vaccine-induced immunity. Several emerging variants have shown decreased susceptibility to neutralization by vaccine induced immunity, most notably the B.1.351 variant, although the overall impact on vaccine efficacy remains to be determined. Here, we present the initial evaluation in mice of two updated COVID-19 mRNA vaccines designed to target emerging SARS-CoV-2 variants: (1) monovalent mRNA-1273.351 encodes for the S protein found in the B.1.351 lineage and (2) mRNA-1273.211 comprising a 1:1 mix of mRNA-1273 and mRNA-1273.351. Both vaccines were evaluated as a 2-dose primary series in mice; mRNA-1273.351 was also evaluated as a booster dose in animals previously vaccinated with 2-doses of mRNA-1273. The results demonstrated that a primary vaccination series of mRNA-1273.351 was effective at increasing neutralizing antibody titers against the B.1.351 lineage, while mRNA-1273.211 was most effective at providing broad cross-variant neutralization in mice. In addition, these results demonstrated a third dose of mRNA-1273.351 significantly increased both wild-type and B.1.351-specific neutralization titers. Both mRNA-1273.351 and mRNA-1273.211 are currently being evaluated in additional pre-clinical challenge models and in phase 1/2 clinical studies.

scholarly journals Comparison of the Immunogenicity and Safety of Three Enhanced Inactivated Poliovirus Vaccines from Different Manufacturers in Healthy Korean Infants: A Prospective Multicenter Study

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 200
Author(s):  
Byung Ok Kwak ◽  
Sang Hyuk Ma ◽  
Su Eun Park ◽  
Seon Hee Shin ◽  
Kyung Min Choi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Prospective Study ◽  
Geometric Mean ◽  
Neutralizing Antibody ◽  
Primary Vaccination ◽  
Reliable Data ◽  
Prospective Multicenter Study ◽  
Serious Adverse Events ◽  
Healthy Infants ◽  
A Prospective Study

The enhanced inactivated poliovirus vaccine was first introduced in 2002, and several inactivated poliovirus vaccines are licensed in Korea. Reliable data by a prospective study on the immunogenicity and safety of the inactivated poliovirus vaccines in Korean infants are required. Normal healthy infants aged 6–12 weeks received three doses of the vaccine (IPVAX™, Imovax Polio™ or Poliorix™) in intervals of 2 months. Neutralizing antibody (NTAb) titers were measured before and 4–6 weeks after three-dose primary vaccination. Immunogenicity was evaluated by seroconversion rates and geometric mean titers obtained by analyzing NTAb titers. Local and systemic adverse events were recorded during 7 days after each vaccination. A total of 150 infants were included: 40 in IPVAX™, 52 in Imovax Polio™, and 58 in Poliorix™. The seroconversion rates for the group vaccinated with IPVAX™ were 100% in types 1, 2 and 3, while those of Imovax Polio™ were 98.1%, 96.2%, 96.2% and those of Poliorix™ were 98.3%, 100%, 100%, respectively. In all groups, injection site redness and irritability were the most common local and systemic adverse events. Neither serious adverse events nor adverse events above grade 2 were reported throughout the study. The currently used inactivated poliovirus vaccines was demonstrated to be safe and immunogenic in healthy Korean infants.

scholarly journals Immunogenicity of Simulated PCECV Postexposure Booster Doses 1, 3, and 5 Years after 2-Dose and 3-Dose Primary Rabies Vaccination in Schoolchildren

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Thavatchai Kamoltham ◽  
Wiravan Thinyounyong ◽  
Pakamatz Khawplod ◽  
Phran Phraisuwan ◽  
Phana Phongchamnaphai ◽  
...  
Keyword(s):  
Booster Dose ◽  
Neutralizing Antibody ◽  
Fold Increase ◽  
Primary Vaccination ◽  
Embryo Cell ◽  
Open Label ◽  
Serious Adverse Events ◽  
Anamnestic Response ◽  
Chick Embryo Cell ◽  
Open Label Phase

Objectives. To assess the immunogenicity of intradermal (ID) booster doses of Purified Chick Embryo Cell rabies vaccine (PCECV, Rabipur) administered to Thai schoolchildren one, three and five years after a primary ID pre-exposure (PrEP) vaccination series.Methods. In this follow-up study of a randomized, open-label, phase II clinical trial, two simulated post-exposure booster doses of PCECV were administered on days 0 and 3 intradermally to 703 healthy schoolchildren, one, three or five years after primary vaccination with either two or three ID doses of 0.1 mL PCECV. Blood was drawn immediately before and 7, 14 and 365 days after the first booster dose to determine rabies virus neutralizing antibody (RVNA) concentrations.Results. An anamnestic response of approximately 30-fold increase in RVNA concentrations was demonstrated within 14 days after booster. All children (100%) developed adequate RVNA concentrations above 0.5 IU/mL. No vaccine related serious adverse events were seen in any of the vaccinees.Conclusion. ID rabies PrEP with PCECV is safe and immunogenic in schoolchildren and the anamnestic response to a two booster dose vaccination series was found to be adequate one, three, and five years after a two- or three-dose primary PrEP vaccination series.

Immune memory response induced in vitro by recombinant hepatitis B surface antigen challenge 13-18 years after primary vaccination

2014 ◽  
Vol 86 (10) ◽  
pp. 1700-1704 ◽  
Author(s):  
Andréa do Livramento ◽  
Júnia Schultz ◽  
Keila Zaniboni Siqueira Batista ◽  
Arício Treitinger ◽  
Caio Maurício Mendes de Cordova ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Primary Vaccination ◽  
Antigen Challenge ◽  
Immune Memory ◽  
Recombinant Hepatitis ◽  
Memory Response

scholarly journals Evaluation of Transplacental Antibody Transfer in SARS-CoV-2-Immunized Pregnant Women

Vaccines ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 101
Author(s):  
Ching-Ju Shen ◽  
Yi-Chen Fu ◽  
Yen-Pin Lin ◽  
Ching-Fen Shen ◽  
Der-Ji Sun ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Antibody Level ◽  
Neutralizing Antibodies ◽  
Dose Group ◽  
Neutralizing Antibody ◽  
Effective Vaccine ◽  
Igg Antibody ◽  
Maternal Mrna ◽  
The One ◽  
Antibody Levels

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during pregnancy could result in adverse perinatal outcome. Clinical data on the assessment of the immune response in vaccinated pregnant women and subsequent transplacental antibody transfer are quite limited. Objective: To assess maternal and neonatal neutralizing antibody levels against both wildtype and Delta (B.1.617.2) variants after maternal mRNA vaccination. Study Design: This cohort study was conducted 29 pregnant women who were vaccinated at least one dose of Moderna (mRNA-1273) vaccine. Both neutralizing antibody (wildtype and Delta variant) and S1 receptor binding domain IgG antibody levels were evaluated in maternal and cord blood on the day of delivery. Results: Superiority of antibody level was significant in fully vaccinated women compared with the one-dose group (maternal sera, median, 97.46%; cord sera, median, 97.37% versus maternal sera, median, 4.01%; cord sera, median, 1.44%). No difference in antibody level was noted in relation to interval of second immunization to delivery in the two-dose group (95.99% in 0–2 weeks, 97.45% in 2–4 weeks, 97.48% in 4–8 weeks, 97.72% in 8–10 weeks). The most pronounced reduction was observed for the Delta variant. The wildtype neutralizing antibody level of full-vaccinated women was not influenced by the pertussis vaccination. Conclusion: The data underscore the importance of full vaccination in pregnancy and support the recommendation of COVID-19 immunization for pregnant women. The lower level of vaccine-induced neutralizing antibodies for the Delta variant indicates insufficient protection for mother and newborn and highlights the need for development of effective vaccine strategies.

scholarly journals Long-Term Antibody and Immune Memory Response Induced by Pulmonary Delivery of the Influenza Iscomatrix Vaccine

2011 ◽  
Vol 19 (1) ◽  
pp. 79-83 ◽  
Author(s):  
Ana Vujanic ◽  
Kenneth J. Snibson ◽  
Janet L. K. Wee ◽  
Stirling J. Edwards ◽  
Martin J. Pearse ◽  
...  
Keyword(s):  
Pulmonary Delivery ◽  
Antigen Challenge ◽  
Immune Memory ◽  
Memory Response ◽  
Mucosal Antibody ◽  
Virus Specific Antibody ◽  
Adjuvant Vaccine ◽  
Functional Antibodies ◽  
Antibody Levels

ABSTRACTPulmonary delivery of an influenza Iscomatrix adjuvant vaccine induces a strong systemic and mucosal antibody response. Since an influenza vaccine needs to induce immunological memory that lasts at least 1 year for utility in humans, we examined the longevity of the immune response induced by such a pulmonary vaccination, with and without antigen challenge. Sheep were vaccinated in the deep lung with an influenza Iscomatrix vaccine, and serum and lung antibody levels were quantified for up to 1 year. The immune memory response to these vaccinations was determined following antigen challenge via lung delivery of influenza antigen at 6 months and 1 year postvaccination. Pulmonary vaccination of sheep with the influenza Iscomatrix vaccine induced antigen-specific antibodies in both sera and lungs that were detectable until 6 months postimmunization. Importantly, a memory recall response following antigenic challenge was detected at 12 months post-lung vaccination, including the induction of functional antibodies with hemagglutination inhibition activity. Pulmonary delivery of an influenza Iscomatrix vaccine induces a long-lived influenza virus-specific antibody and memory response of suitable length for annual vaccination against influenza.

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