Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study.

Background: Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.

Methods: In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18-85 years were recruited from nine hospitals across seven cities in India.

Safety and Immunogenicity of a novel three-dose recombinant nanoparticle rabies G protein vaccine administered as simulated post exposure immunization: A randomized, comparator controlled, multicenter, phase III clinical study.

Background: Rabies vaccines are lifesaving in human post animal exposure. However, the compliance to the complete course of vaccine is found to be only 60%. Hence, there is a need for safe and immunogenic, shorter course vaccine that can enhance the compliance and effectively prevent the disease.

Comparison of a Novel Human Rabies Monoclonal Antibody to Human Rabies Immunoglobulin for Postexposure Prophylaxis: A Phase 2/3, Randomized, Single-Blind, Noninferiority, Controlled Study.

Background: Lack of access to rabies immunoglobulin (RIG) contributes to high rabies mortality. A recombinant human monoclonal antibody (SII RMAb) was tested in a postexposure prophylaxis (PEP) regimen in comparison with a human RIG (HRIG)-containing PEP regimen.

Methods: This was a phase 2/3, randomized, single-blind, noninferiority study conducted in 200 participants with World Health Organization category III suspected rabies exposures.

Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen).

Despite availability of effective rabies vaccines, India has the highest global mortality rate for rabies. Low socio-economic communities are most affected due to lack of awareness of the disease and poor compliance to post-exposure prophylactic regimens. Currently, the only approved intramuscular regimen for post-exposure prophylaxis (PEP) against rabies in India is the Essen regimen, which consists of 5 injections administered over 5 separate days in a period of one month.

Safety and Immunogenicity of purified chick embryo cell rabies vaccine (VaxiRab N) administered intradermally as post exposure prophylaxis.

The affordability to rabies vaccine for intramuscular administration in post exposure prophylaxis is a major constraint. Therefore, in countries, where there are financial constraints, World Health Organization recommends intradermal rabies vaccination that reduces the quantity and cost of vaccination. This study was done to evaluate the safety and immunogenicity of indigenously developed rabies vaccine (VaxiRab N) in comparison to a WHO recommended rabies vaccine (Rabipur) with demonstrated efficacy when administered by intradermal route using updated Thai Red Cross regimen.

Safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-DT): a multicenter, open-label, non-randomized, phase III clinical trial.

Objective: To assess the safety and immunogenicity of a quadrivalent meningococcal (groups A,C,Y,W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-DT) in India.

Design: Open-label, descriptive, non-randomized study.

Setting: Three medical college hospitals, one each in New Delhi, Bengaluru and Mumbai, India.

Assessing safety and immunogenicity of post-exposure prophylaxis following interchangeability of rabies vaccines in humans.

Rabies post exposure prophylaxis with cell culture vaccines by either intramuscular route or intradermal route spans over a period of one month. World Health Organization recommends completing post exposure prophylaxis against rabies with the same cell culture or embryonated egg rabies vaccine and with same route of administration and any deviation from this shall be an exception. In the present study, the safety and immunogenicity of rabies post-exposure prophylaxis was studied prospectively in 90 animal bite cases that had interchangeability of rabies vaccines either by route of administration or brand/type and such changes had occurred due to logistical/financial problems.

Pre-exposure prophylaxis against rabies in children: safety of purified chick embryo cell rabies vaccine (Vaxirab N) when administered by intradermal route.

WHO recommends that children living in highly endemic regions be considered for pre-exposure prophylaxis with rabies vaccine, since they will be at continual, frequent or increased risk of exposure to the animal bites. The recommendations will come from WHO only after it has been proven by many previous scientific studies among children which have shown that pre-exposure prophylaxis using Purified Chick Embryo Cell Vaccine (PCECV) is safe and well tolerated. This has been mentioned in the discussion.

Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India.

Zydus Cadila Health care, India developed a new purified chick embryo cell rabies vaccine (PCECV, Vaxirab-N; 1 mL) by adapting Pitman-Moore strain of virus on to the chick embryo fibroblast cell line in 2006. During 2007-10, a series of safety and immunogenicity studies were conducted as per ICH-GCP guidelines after obtaining permission from Drug Controller General of India. In the first study, Vaxirab-N was administered to 35 healthy adult volunteers by intramuscular (IM) route using pre exposure regimen.

Pre-exposure prophylaxis against rabies in children: safety of purified chick embryo cell rabies vaccine (Vaxirab N) when administered by intradermal route.

Animal bites in humans are a public health problem. Children are the most frequently exposed, representing 50% of human exposures in canine rabies infected areas. Pre-exposure vaccination using cell culture vaccines is a safe and effective method of preventing rabies among children in these highly endemic regions.

Evaluation of a one week intradermal regimen for rabies post-exposure prophylaxis: results of a randomized, open label, active-controlled trial in healthy adult volunteers in India.

The currently recommended intradermal regimen for post-exposure prophylaxis spreads over a month period which many times lead to low compliance from the patients. There is a need to introduce and evaluate short course regimens to overcome this problem. This study was conducted to evaluate the immunogenicity and safety of a "new one week intradermal regimen" for rabies post-exposure prophylaxis.

Is the skin sensitivity test required for administering equine rabies immunoglobulin?

Background: Rabies immunoglobulins are life-saving in patients with severe exposure to rabies. Despite the high degree of purification of equine rabies immunoglobulin (ERIG), the product inserts still recommend a skin sensitivity test before administration of this heterologous serum. A recent WHO recommendation states that there are no scientific grounds for performing a skin test before administering ERIG because testing does not predict reactions and it should be given irrespective of the result of the test.

Assessing the relationship between antigenicity and immunogenicity of human rabies vaccines when administered by intradermal route: results of a metaanalysis.

The metadata of 10 published studies and 3 vaccine trial reports comprising of 19 vaccine cohorts from four countries conducted over a period of 23 years (1986 - 2009) was used for metaanalysis. The vaccines studied were purified chick embryo cell vaccine (Rabipur, India & Germany), purified vero cell rabies vaccine (Verorab, France; Indirab, India) & human diploid cell vaccine (MIRV, France).The potency of these vaccines varied from 0.

Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine.

A chromatographically purified Vero cell rabies vaccine, Indirab manufactured by Bharat Biotech International Limited, Hyderabad, India was subjected to safety and immunogenicity studies by both intramuscular and intradermal routes of administration in parallel with a reference vaccine, Verorab. A Pre-exposure study was undertaken in 239 subjects by intramuscular (IM) route (Study I), Post-exposure study in 188 patients by intramuscular route (Study II) and Simulated post-exposure study in 134 subjects by intradermal (ID) route (Study III). All subjects in these studies were administered with either the test or the reference vaccine as per WHO approved intramuscular and intradermal regimens.

Assessing the safety of post-exposure rabies immunization in pregnancy.

Fourteen pregnant women who received rabies post-exposure prophylaxis (PEP) at the anti-rabies clinic (ARC) of Kempegowda Institute of Medical Sciences (KIMS) were followed up for assessing the safety of modern rabies vaccines and equine rabies immunoglobulin (ERIG) in pregnancy. The women were in the age range of 18-28 years, mostly from urban area (64%) and exposed to suspect rabid dogs (86%). They had received purified vero cell rabies vaccine (Verorab = 8 and Abhayrab = 4), purified chick embryo cell vaccine (Rabipur = 2) by Essen regimen; and equine rabies immunoglobulin (Equirab = 7 and Pasteur anti-rabies serum = 1).

Boosting effect of purified chick embryo cell rabies vaccine using the intradermal route in persons previously immunized by the intramuscular route or vice versa.

Background: At present, in the event of re-exposure to rabies, 2 booster doses are recommended for people who have been previously vaccinated with cell culture rabies vaccines by the conventional intramuscular route. As the intradermal route of vaccination is likely to be introduced in the future, we investigated the immune response to a cell culture rabies vaccine after crossing over from the intramuscular to the intradermal route and vice versa.

Methods: Twenty healthy adult volunteers who had received a primary course of rabies vaccination with purified chick embryo cell rabies vaccine by either the intramuscular (n = 10) or intradermal (n = 10) route received booster vaccination with the same vaccine by the alternative route.