Accession Number:

ADA379283

Title:

Safety, Immunogenicity and Lot Stability of the Whole Cell/Recombinant B Subunit (WC/rCTB) Cholera Vaccine in Peruvian Adults and Children

Descriptive Note:

Journal article

Corporate Author:

NAVAL MEDICAL RESEARCH INST DETACHMENT LIMA (PERU)

Personal Author(s):

• Taylor, David N.
• Cardenas, Vicky
• Perez, Juan
• Puga, ROmulo
• Svennerholm, Ann-Mari

Report Date:

1999-01-01

Pagination or Media Count:

6.0

Abstract:

To assess the safety, immunogenicity, and lot stability of the whole cellrecombinant B subunit cholera vaccine, 2 lots manufactured in June 1991 and February 1992 were tested in January 1995. Two oral doses of vaccine or placebo given 2 weeks apart were given with buffer to 216 Peruvian adults and children. Symptoms were elicited for 3 days after each dose. Serum and plasma specimens obtained from each volunteer before vaccination and 10- 14 days after the second dose were tested for vibriocidal and anti-cholera toxin antibodies. The vaccine was well- tolerated. Nearly half of the 100 vaccines had pre-vaccination vibriocidal titers greater than 140. Elevated titers were observed in 22 of 37 children 2-5 years of age compared with 66 of 63 vaccines 6-65 years P 0.001 A greater than 2-fold serum vibriocidal response was observed in 55 of 100 vaccines and 6 of 32 placebo recipients. An elevated pre- vaccination titer greater than 140 did not change the proportion of vaccines who responded with a greater than 2-fold increase in vibriocidal titer 51 versus 59, difference not significant, but did change the proportion responding with a greater than - fold increase 41 versus 22 P 0.05. The vibriocidal seroconversion rate was lowest in children 2-5 years old despite low pre-vaccination titers. Two-fold or greater serum antitoxic responses in IgA and IgG were observed in 90 of the vaccinees 4-fold responses were seen in 65-70 of the vaccinees with a 6-8-fold increase over baseline. Plasma specimens were as good as sera for determining anti-toxic antibodies by ELISA, but were less satisfactory for determining vibriocidal antibody titers.

Descriptors:

• *CHOLERA
• *IMMUNIZATION
• *TOXINS AND ANTITOXINS
• *VACCINES
• *VOLUNTEERS
• BASE LINES
• BLOOD SERUM
• CELLS(BIOLOGY)
• CHILDREN
• DOSAGE
• ORAL DOSAGE
• PLACEBOS
• PLASMAS(PHYSICS)
• RESPONSE(BIOLOGY)
• SIGNS AND SYMPTOMS

Subject Categories:

• Anatomy and Physiology
• Medicine and Medical Research
• Toxicology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE