A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults.

Due to waning immunity following primary immunization with COVID-19 vaccines, booster doses may be required. The present study assessed a heterologous booster of SII-NVX-CoV2373 (spike protein vaccine) in adults primed with viral vector and inactivated vaccines. In this Phase 3, observer-blind, randomized, active controlled study, a total of 372 adults primed with two doses of ChAdOx1 nCoV-19 (n = 186) or BBV152 (n = 186) at least six months ago, were randomized to receive a booster of SII-NVX-CoV2373 or control vaccine (homologous booster of ChAdOx1 nCoV-19 or BBV152).

A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine.

Yellow fever, a mosquito-borne flavivirus infection, is an important public health problem in Africa and Latin America. A Yellow Fever vaccine (YFV) was developed and tested in a study in India. This was a Phase I, open-label, randomized, controlled study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL (Sanofi-Pasteur) in 1:1:1 ratio.

Safety and immunogenicity of a new purified vero cell rabies vaccine (PVRV) administered by intramuscular and intradermal routes in healthy volunteers.

Background: Rabies is 100% fatal but preventable with modern vaccines and immunoglobulins. There is a huge demand for rabies vaccines in developing countries of Asia and Africa. We have developed a new purified vero cell rabies vaccine (PVRV) and evaluated its safety and immunogenicity in healthy volunteers by intramuscular (IM) and intradermal (ID) routes of vaccination.

A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac (®) ) in India.

A live attenuated pandemic H1N1 influenza vaccine was developed in India. A post marketing surveillance was conducted retrospectively in healthy individuals (³ 3 years) who were vaccinated intranasally around one year before. After consent, the subjects recorded adverse events developing within 42 days.

Safety and immunogenicity of an adjuvanted whole virion, inactivated A (H1N1) 2009 influenza vaccine in young and elderly adults, and children.

An alum adjuvanted whole virion inactivated vaccine against the A (H1N1) 2009 pandemic virus was developed in India. Two double-blind, randomized studies were conducted. Fifty adults (18-50 years) were enrolled in the Phase I study, whereas the Phase II/III study consisted of 330 adults (≥18 years) and children ≥3 years.

Immunogenicity of two diphtheria-tetanus-whole cell pertussis-hepatitis B vaccines in infants: a comparative trial.

Aim: Because of the high mother-to-infant transmissibility of hepatitis B (HB) infection, neonatal vaccination is necessary, but the further doses of HB vaccines can be combined with conventional diphtheria-tetanus-whole cell pertussis (DTPw) vaccines. We compared immunogenicity and reactogenicity of two tetravalent vaccines in Indian children, who after neonatal HB immunization, were vaccinated thrice with one of these vaccines.

Methods: In this open-label randomized study, 287 infants received a dose of an Indian- (Q-Vac (TM )) or European-made (Tritanrix-HB (TM )) tetravalent vaccine at age 6, 10, and 14 weeks.

Immunogenicity of two modern tissue culture rabies vaccines in pre-exposure prophylaxis.

Pre-exposure prophylaxis was given to employees supposed to be involved in rabies vaccine production in India. Prior to availability of the manufacturer's own human diploid cell (HDC) vaccine (Rabivax), immunization was executed with a chick embryo cell (CEC) vaccine (Rabipur). This constellation gave an opportunity to compare retrospectively immunogenicity of these two vaccines.

Immunogenicity of a new, low-cost recombinant hepatitis B vaccine derived from Hansenula polymorpha in adults.

Background: Hepatitis B virus (HBV) infection is highly prevalent world over, especially in developing countries. A new recombinant hepatitis B virus (GeneVac-B; Serum Institute of India Ltd.) vaccine is developed using Hansenula polymorpha yeast.

No definitive evidence for L-Zagreb mumps strain associated aseptic meningitis: a review with special reference to the da Cunha study.

The study by da Cunha et al. published in 2002 reported that MMR vaccine containing L-Zagreb mumps strain manufactured by Serum Institute of India Ltd. caused a high incidence of aseptic meningitis (AM) from routine surveillance during two mass immunization campaigns (MIC) conducted in 1998 in two states in Brazil.