Evaluation of Vaccines

Clinical Development of ROTAVAC®

Conducted phase I to III clinical trials of the indigenously manufactured ROTAVAC® vaccine [Vaccine 2006; 24:5817-23; J Infect Dis 2009; 421-9; Lancet 2014; doi:10.1016/S0140-6736(13)62630-6, Vaccine 2014; 32 (Suppl 1):A134-139); Heliyon 2017; e00302]. The vaccine is licensed and was introduced into national program by Government of India in March 2016.

We also examined the risk of intussusception after ROTAVAC® vaccination among Indian infants during pilot rollout in the public health system in three states: Himachal Pradesh, Maharashtra and Tamil Nadu. The study showed no increased risk of intussusception associated with any of the three doses of the ROTAVAC® vaccine or combinations of doses within 21 days of vaccination compared to the control period in the study sites [Vaccine 2020;38(33):5241-5248].

Predictors of Poor Immune Response to Rotavirus Vaccine in Infants

The effect of breastfeeding on the immunogenicity of Rotarix®, a two-dose oral monovalent rotavirus vaccine, was examined in a community-based trial in New Delhi, India. Four hundred mother–infant pairs were randomized into two equal groups. Infants were aged 6–7 weeks at enrollment. Mothers were encouraged to either breastfeed or to withhold breastfeeding during the 30 min prior to and after each vaccine dose was administered. We collected blood specimens from infants at enrollment and 4 weeks after the second vaccine dose. Blood and breast milk specimens were obtained from mothers at baseline and breast milk specimens were collected at the time of the second vaccine dose. There was no difference in the proportion who seroconverted between the two groups (26% vs 27%; p = 0.92). Factors other than maternal anti-rotavirus antibodies probably explain why infants in low-and middle-income settings respond poorly to live oral rotavirus vaccines. Vaccine 32S (2014) A134–A139. Trials 2014, 15:256.

Clinical Development of ROTASIIL®

Contributed to clinical evaluation of the freeze dried and liquid formulation of ROTASIIL manufactured by Serum Institute of India Limited.

The vaccine was launched in national immunization program in April 2018 [Vaccine 2017;6228-6237; Vaccine 2019;37(19):2554-2560].

Serum Institute of India’s 10-valent Pneumococcal Conjugate Vaccine

We are evaluating the immunogenicity, safety and tolerability of a 10-valent Pneumococcal Conjugate Vaccine in Healthy Indian Infants in a phase III, multicentre, randomized, double-blind controlled trial. The vaccine is administered to infants as two primary doses at 6 and 14 weeks of age followed by booster at 9 months. Infants are followed till 4 weeks post booster dose. Status: Study Ongoing (Trial Registration CTRI/2019/08/020939).

Serum Institute of India’s Meningococcal ACYWX Conjugate Vaccine (NmCV-5)

The lot to lot consistency of a pentavalent Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and its safety and immunogenicity as compared to the licensed tetravalent Meningococcal ACWY Vaccine Menactra® is being evaluated in healthy adults aged 18-85 yrs. This is a phase 3, multicentre, randomized, observer-blind, controlled trial. The vaccine is given as a single dose intramuscular injection and participants are followed for 6 months. Status: Study Ongoing (Trial Registration CTRI/2019/12/022436)

Serum Institute of India’s HEXASIIL (DTwPHepB-IPV-Hib) Vaccine

The immunogenicity and safety of HEXASIILTM (DTwP-HepB-IPV-Hib) vaccine in comparison with  Pentavac (DTwP-HepB-Hib) + Poliovac (IPV) vaccines, administered as separate injections in Indian toddlers and infants is being assessed in a  phase II/III, multicentre, open label, randomized, active-controlled trial. The vaccines are being administered to infants in three primary doses at 6, 10 and 14 weeks of age followed by booster after 12 months. Infants are followed till 4 weeks post booster dose. Status: Study Ongoing (Trial Registration CTRI/2019/11/022052).