Safety and immunogenicity of two recombinant vaccines based upon plasmodium falciparum merozoite surface protein 1 (P30P2 MSP-1 191 19)

W. Keitel, K. Kester, R. Atmar, A. Clinton White, C. Diggs, W. R. Ballou, D. Kaslow

Research output: Contribution to journalArticle

Abstract

The safety and immunogenicity of 20 and 200 ug doses of 2 yeast-derived malaria vaccines were evaluated in a phase 1 randomized clinical trial. Healthy adults (N=40) were given up to 3 monthly doses of alum-adjuvanted vaccine containing a 19kD fragment of MSP-1 (3D7 or FVO strain) fused to tetanus T-helper epitopes P30 & P2 (N=8 for each vaccine and dose group); 3 doses of hepatitis B vaccine (HBV) (N=4); or adult tetanus-diphtheria booster (Td) followed by placebo (N=4). The first 2 doses of vaccine were well tolerated. After the 3rd dose 3 subjects had hypersensitivity reactions. 2 (1-3D7, 1-FVO) developed bilateral injection site reactions, 1 with generalized skin rash. 1 subject given 200 ug of FVO had histamine-assd hypotension and flushing resulting in trial termination. 2 or 3 doses elicited =>4x increases in ELISA antibody to MSP-1 19 in 5/16 given 20 ug and in 8/16 given 200 ug; 0/8 given HBV or Td responded. Changes in adjuvant and/or schedule may improve the safety and immunogenicity of MSP-1 19 vaccines.

Original languageEnglish (US)
Pages (from-to)466
Number of pages1
JournalClinical Infectious Diseases
Volume25
Issue number2
StatePublished - 1997
Externally publishedYes

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Merozoite Surface Protein 1
Synthetic Vaccines
Plasmodium falciparum
Tetanus
Vaccines
Safety
Hepatitis B Vaccines
Diphtheria
Malaria Vaccines
Clinical Trials, Phase I
Exanthema
Hypotension
Histamine
Epitopes
Appointments and Schedules
Hypersensitivity
Randomized Controlled Trials
Yeasts
Enzyme-Linked Immunosorbent Assay
Placebos

ASJC Scopus subject areas

  • Immunology

Cite this

Safety and immunogenicity of two recombinant vaccines based upon plasmodium falciparum merozoite surface protein 1 (P30P2 MSP-1 191 19). / Keitel, W.; Kester, K.; Atmar, R.; White, A. Clinton; Diggs, C.; Ballou, W. R.; Kaslow, D.

In: Clinical Infectious Diseases, Vol. 25, No. 2, 1997, p. 466.

Research output: Contribution to journalArticle

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