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Immunogenicity, safety and lot consistency in adults of a chromatographically purified Vero-cell rabies vaccine: a randomized, double-blind trial with human diploid cell rabies vaccine
- Source :
- Vaccine. 19:4635-4643
- Publication Year :
- 2001
- Publisher :
- Elsevier BV, 2001.
-
Abstract
- The immunogenicity and safety of a chromatographically purified rabies vaccine (CPRV) was evaluated using US veterinary medical students. In the first study, 242 healthy adults were enrolled in a randomized, modified double-blind, multicenter trial and received five doses of either CPRV or human diploid cell vaccine (HDCV) by intramuscular injection on days 0, 3, 7, 14, and 28 concurrently with human rabies immunoglobulin in a simulated post-exposure prophylaxis regimen. Post-immunization titers in the CPRV and HDCV groups reached 0.5 IU/ml (the WHO-recommended minimally acceptable titer) or greater in all subjects in both vaccine groups by day 14 and remained above that level through day 90. In the second study, 438 healthy adults were enrolled in a randomized, double-blind, multicenter trial and assigned to receive five doses from one of three lots of CPRV by intramuscular injection on days 0, 3, 7, 14, and 28 in a simulated post-exposure prophylaxis regimen to evaluate lot consistency. Post-immunization titers rapidly increased to over 0.5 IU/ml by day 14 for all subjects and remained above that level through day 42 when the study was terminated. The three lots were considered equivalent. The percentage of subjects with at least one local reaction during the five-dose regimen was slightly lower in the CPRV group than in the HDCV group (P=0.06). The most frequently reported local reaction for all doses of vaccine was pain at the injection site. Headache, myalgia, and malaise were the most frequently reported systemic events. The percentage of subjects with at least one systemic event was significantly lower for CPRV (P=0.0084). No vaccine-related serious adverse reaction was reported in these studies. The results of these studies indicate that CPRV administered intramuscularly to healthy adults is immunogenic and is associated with fewer local and systemic reactions than HDCV.
- Subjects :
- Adult
Male
medicine.medical_specialty
Virus Cultivation
Pain
Antibodies, Viral
medicine.disease_cause
Injections, Intramuscular
law.invention
Rabies vaccine
Double-Blind Method
Randomized controlled trial
Lymphadenitis
law
Propiolactone
Internal medicine
Multicenter trial
Chlorocebus aethiops
medicine
Animals
Humans
Prospective Studies
Adverse effect
Vero Cells
Immunization Schedule
Chromatography
General Veterinary
General Immunology and Microbiology
business.industry
Pruritus
Rabies virus
Headache
Public Health, Environmental and Occupational Health
medicine.disease
Regimen
Infectious Diseases
Rabies Vaccines
Vaccines, Inactivated
Erythema
Immunology
Molecular Medicine
Female
Rabies
Safety
Intramuscular injection
business
medicine.drug
Subjects
Details
- ISSN :
- 0264410X
- Volume :
- 19
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....9b72602ac73ae192fb7d0c1e2117e574