A5101664839- SARS-CoV-2 and COVID-19 Research
- Animal Virus Infections Studies
- Viral gastroenteritis research and epidemiology
- Immunotherapy and Immune Responses
- SARS-CoV-2 detection and testing
- COVID-19 Clinical Research Studies
- Viral Infections and Immunology Research
- Cytomegalovirus and herpesvirus research
- Respiratory viral infections research
- Hepatitis B Virus Studies
- Viral Infections and Vectors
- Cervical Cancer and HPV Research
- Maternal and fetal healthcare
- Herpesvirus Infections and Treatments
- Mosquito-borne diseases and control
- Vaccine Coverage and Hesitancy
- RNA Interference and Gene Delivery
- Anesthesia and Pain Management
- Pregnancy and preeclampsia studies
- vaccines and immunoinformatics approaches
- Viral Infections and Outbreaks Research
- Genital Health and Disease
- Birth, Development, and Health
- Virus-based gene therapy research
- Influenza Virus Research Studies
Moderna Therapeutics (United States)
2021-2025
Indian Statistical Institute
2014-2023
Merck & Co., Inc., Rahway, NJ, USA (United States)
2016-2023
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences
2017-2023
Pain Clinic of India
2023
Homi Bhabha National Institute
2020-2023
Bhabha Atomic Research Centre
2020-2023
Medical College and Hospital, Kolkata
2015-2022
Indian Institute of Science Education and Research Kolkata
2020
Govind Ballabh Pant Hospital
2020
The safety and immunogenicity of the bivalent omicron-containing mRNA-1273.214 booster vaccine are not known.In this ongoing, phase 2-3 study, we compared 50-μg (25 μg each ancestral Wuhan-Hu-1 omicron B.1.1.529 [BA.1] spike messenger RNAs) with previously authorized mRNA-1273 booster. We administered or as a second in adults who had received two-dose (100-μg) primary series first (50-μg) dose (≥3 months earlier). objectives were to assess safety, reactogenicity, at 28 days after...
Respiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized prefusion F glycoprotein, is under clinical investigation. Download a PDF of Research Summary. In this ongoing, randomized, double-blind, placebo-controlled, phase 2–3 trial, we randomly assigned, in 1:1 ratio, adults 60 years age or to receive one dose mRNA-1345 (50 μg) placebo. The two primary efficacy end points were prevention...
Vaccination of children to prevent coronavirus disease 2019 (Covid-19) is an urgent public health need. The safety, immunogenicity, and efficacy the mRNA-1273 vaccine in 6 11 years age are unknown.Part 1 this ongoing phase 2-3 trial was open label for dose selection; part 2 observer-blinded, placebo-controlled expansion evaluation selected dose. In 2, we randomly assigned (6 age) a 3:1 ratio receive two injections (50 μg each) or placebo, administered 28 days apart. primary objectives were...
Updated immunization strategies are needed to address multiple severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. Here we report interim results from an ongoing, open-label phase 2/3 trial evaluating the safety and immunogenicity of bivalent Coronavirus Disease 2019 (COVID-19) vaccine candidate mRNA-1273.211, which contains equal mRNA amounts encoding ancestral SARS-CoV-2 Beta variant spike proteins, as 50-µg (n = 300) 100-µg 595) first booster doses administered...
The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown.Part 1 this ongoing phase 2-3 trial was open label for dose selection; part 2 an observer-blinded, placebo-controlled evaluation selected dose. In 2, we randomly assigned (6 months to 5 years age) a 3:1 ratio receive two 25-μg injections or placebo, administered 28 days apart. primary objectives were evaluate safety reactogenicity determine...
Abstract Rising breakthrough infections of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in previously immunized individuals have raised concerns for the need a booster vaccine dose to combat waning antibody levels and new variants. Here we report results open-label, non-randomized part B phase trial which evaluated safety immunogenicity injection 50 µg disease 2019 (COVID-19) mRNA-1273 344 adult participants 6–8 months earlier with primary series two doses or 100 (...
Abstract Background Subvariants of the severe acute respiratory syndrome coronavirus (SARS-CoV-2) omicron XBB-lineage have potential to escape immunity provided by prior infection or vaccination. For Covid-19 immunizations beginning in Fall 2023, U.S. FDA has recommended updating a monovalent XBB.1.5-containing vaccine. Methods In this ongoing, phase 2/3 study participants were randomized 1:1 receive 50-µg doses mRNA-1273.815 (50-µg XBB.1.5 spike mRNA) mRNA-1273.231 bivalent (25-µg and 25-µg...
Monovalent Omicron XBB.1.5-containing vaccines were approved for coronavirus disease 2019 (COVID-19) 2023-2024 immunizations.
This ongoing, open-label, phase 2/3 trial compared the safety and immunogenicity of Omicron BA.4/BA.5-containing bivalent mRNA-1273.222 vaccine with ancestral Wuhan-Hu-1 mRNA-1273 as booster doses. Two groups adults who previously received primary vaccination series doses were enrolled in a sequential, nonrandomized manner single-second boosters (n = 376) or 511). Primary objectives noninferiority superiority neutralizing antibody (nAb) responses against BA.4/BA.5 SARS-CoV-2 D614G mutation...
Abstract Background An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults. Methods Based on a randomized, observer-blind, placebo-controlled design, this phase 1 dose-ranging study evaluated the safety, reactogenicity, and immunogenicity of mRNA-1345 adults aged 65 79 years. Participants were randomized receive dose (12.5, 25, 50, 100, or 200 µg) placebo matched booster at 12 months. Results Overall,...
Abstract Background mRNA-1283 is an investigational COVID-19 mRNA vaccine encoding the receptor-binding and N-terminal domains of SARS-CoV-2 spike protein in contrast to original mRNA-1273, which encodes full-length protein. Methods A phase 2a, dose-ranging, observer-blind, randomized study (NCT05137236) conducted adults (≥18 years) previously vaccinated with mRNA-1273 evaluated safety immunogenicity a single dose (2.5, 5, 10 µg) its bivalent formulation, mRNA-1283.211 (5 µg; Beta) against...
The long-term effectiveness of the quadrivalent human papillomavirus (qHPV) vaccine was assessed by monitoring combined incidence cervical intraepithelial neoplasia (CIN2, CIN3), adenocarcinoma in situ (AIS), and cancer related to HPV16 or HPV18.Women from Nordic countries Denmark, Iceland, Norway, Sweden who received a 3-dose regimen qHPV beginning FUTURE II (Females United Unilaterally Reduce Endo/Ectocervical Disease; V501-015, base study NCT00092534) are followed through different...
The mRNA-1345 vaccine demonstrated efficacy against respiratory syncytial virus (RSV) disease with acceptable safety in adults aged ≥60 years the ConquerRSV trial. Here, humoral immunogenicity results from trial are presented.
This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP).Overall, 1197 subjects were randomized 2:2:2:2:1; 1194 vaccinated with 1 dose 3 lots rVSVΔG- ZEBOV-GP (2 × 107 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot rVSVΔG-ZEBOV-GP (1 108 pfu, 264; or placebo (n 133). Daily temperatures and adverse events (AEs) recorded days to 42 postvaccination. Solicited AEs...
A conditionally replication-defective human cytomegalovirus (CMV) vaccine (V160) derived from AD169 and genetically engineered to express CMV pentameric complex (gH/gL/pUL128/pUL130/pUL131) was developed evaluated for phase 1 safety immunogenicity in CMV-seronegative CMV-seropositive adults.Subjects received 3 doses of V160 or placebo on day 1, month 6. Four dose levels, formulated with without aluminum phosphate adjuvant, were evaluated. Injection-site systemic adverse events (AEs) viral...
Abstract We previously presented day 29 interim safety and immunogenicity results from a phase 2/3 study (NCT04927065) comparing the Omicron-BA.1-containing bivalent vaccine mRNA-1273.214 (50-µg) to 50-µg mRNA-1273 booster in adults who received primary series (100-µg) first dose. Primary endpoints were safety, non-inferiority of neutralizing antibody (nAb) seroresponse against Omicron BA.1, superiority nAb response Omicron-BA.1, ancestral SARS-CoV-2 for second boosters versus at days 91....
Primary vaccination with mRNA-1273 (100-µg) was safe and efficacious at preventing coronavirus disease 2019 (COVID-19) in the previously reported, blinded Part A of phase 3 Coronavirus Efficacy (COVE; NCT04470427) trial adults (≥18 years) across 99 U.S. sites. The open-label (Parts B C) primary objectives were evaluation long-term safety effectiveness plus a 50-µg booster dose; immunogenicity secondary objective. Of 29,035 participants, 19,609 received boosters (mRNA-1273 [n = 9647];...