A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel® with CPG 7909, using two different formulations and dosing intervals

Ruth D. Ellis, Gregory E D Mullen, Mark Pierce, Laura B. Martin, Kazutoyo Miura, Michael P. Fay, Carole A. Long, Donna Shaffer, Allan Saul, Louis H. Miller, Anna P Durbin

Research output: Contribution to journalArticle

Abstract

A Phase 1 study was conducted in 24 malaria naïve adults to assess the safety and immunogenicity of the recombinant protein vaccine apical membrane antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with CPG 7909 in two different formulations (phosphate buffer and saline), and given at two different dosing schedules, 0 and 1 month or 0 and 2 months. Both formulations were well tolerated and frequency of local reactions and solicited adverse events was similar among the groups. Peak antibody levels in the groups receiving CPG 7909 in saline were not significantly different than those receiving CPG 7909 in phosphate. Peak antibody levels in the groups vaccinated at a 0,2 month interval were 2.52-fold higher than those vaccinated at a 0,1 month interval (p = 0.037, 95% CI 1.03, 4.28). In vitro growth inhibition followed the antibody level: median inhibition was 51% (0,1 month interval) versus 85% (0,2 month interval) in antibody from samples taken 2 weeks post-second vaccination (p = 0.056).

Original languageEnglish (US)
Pages (from-to)4104-4109
Number of pages6
JournalVaccine
Volume27
Issue number31
DOIs
StatePublished - Jun 24 2009

Fingerprint

Malaria Vaccines
Aluminum Hydroxide
antigens
Antigens
antibodies
Membranes
Antibodies
blood
Phosphates
phosphates
Synthetic Vaccines
Recombinant Proteins
recombinant proteins
malaria
growth retardation
Malaria
Appointments and Schedules
Buffers
Vaccination
buffers

Keywords

  • Apical membrane antigen 1
  • Falciparum
  • Malaria

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel® with CPG 7909, using two different formulations and dosing intervals. / Ellis, Ruth D.; Mullen, Gregory E D; Pierce, Mark; Martin, Laura B.; Miura, Kazutoyo; Fay, Michael P.; Long, Carole A.; Shaffer, Donna; Saul, Allan; Miller, Louis H.; Durbin, Anna P.

In: Vaccine, Vol. 27, No. 31, 24.06.2009, p. 4104-4109.

Research output: Contribution to journalArticle

Ellis, RD, Mullen, GED, Pierce, M, Martin, LB, Miura, K, Fay, MP, Long, CA, Shaffer, D, Saul, A, Miller, LH & Durbin, AP 2009, 'A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel® with CPG 7909, using two different formulations and dosing intervals', Vaccine, vol. 27, no. 31, pp. 4104-4109. https://doi.org/10.1016/j.vaccine.2009.04.077
Ellis, Ruth D. ; Mullen, Gregory E D ; Pierce, Mark ; Martin, Laura B. ; Miura, Kazutoyo ; Fay, Michael P. ; Long, Carole A. ; Shaffer, Donna ; Saul, Allan ; Miller, Louis H. ; Durbin, Anna P. / A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel® with CPG 7909, using two different formulations and dosing intervals. In: Vaccine. 2009 ; Vol. 27, No. 31. pp. 4104-4109.
@article{550d3eff9dbe48c99d1a16abd9da5028,
title = "A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel{\circledR} with CPG 7909, using two different formulations and dosing intervals",
abstract = "A Phase 1 study was conducted in 24 malaria na{\"i}ve adults to assess the safety and immunogenicity of the recombinant protein vaccine apical membrane antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with CPG 7909 in two different formulations (phosphate buffer and saline), and given at two different dosing schedules, 0 and 1 month or 0 and 2 months. Both formulations were well tolerated and frequency of local reactions and solicited adverse events was similar among the groups. Peak antibody levels in the groups receiving CPG 7909 in saline were not significantly different than those receiving CPG 7909 in phosphate. Peak antibody levels in the groups vaccinated at a 0,2 month interval were 2.52-fold higher than those vaccinated at a 0,1 month interval (p = 0.037, 95{\%} CI 1.03, 4.28). In vitro growth inhibition followed the antibody level: median inhibition was 51{\%} (0,1 month interval) versus 85{\%} (0,2 month interval) in antibody from samples taken 2 weeks post-second vaccination (p = 0.056).",
keywords = "Apical membrane antigen 1, Falciparum, Malaria",
author = "Ellis, {Ruth D.} and Mullen, {Gregory E D} and Mark Pierce and Martin, {Laura B.} and Kazutoyo Miura and Fay, {Michael P.} and Long, {Carole A.} and Donna Shaffer and Allan Saul and Miller, {Louis H.} and Durbin, {Anna P}",
year = "2009",
month = "6",
day = "24",
doi = "10.1016/j.vaccine.2009.04.077",
language = "English (US)",
volume = "27",
pages = "4104--4109",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "31",

}

TY - JOUR

T1 - A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel® with CPG 7909, using two different formulations and dosing intervals

AU - Ellis, Ruth D.

AU - Mullen, Gregory E D

AU - Pierce, Mark

AU - Martin, Laura B.

AU - Miura, Kazutoyo

AU - Fay, Michael P.

AU - Long, Carole A.

AU - Shaffer, Donna

AU - Saul, Allan

AU - Miller, Louis H.

AU - Durbin, Anna P

PY - 2009/6/24

Y1 - 2009/6/24

N2 - A Phase 1 study was conducted in 24 malaria naïve adults to assess the safety and immunogenicity of the recombinant protein vaccine apical membrane antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with CPG 7909 in two different formulations (phosphate buffer and saline), and given at two different dosing schedules, 0 and 1 month or 0 and 2 months. Both formulations were well tolerated and frequency of local reactions and solicited adverse events was similar among the groups. Peak antibody levels in the groups receiving CPG 7909 in saline were not significantly different than those receiving CPG 7909 in phosphate. Peak antibody levels in the groups vaccinated at a 0,2 month interval were 2.52-fold higher than those vaccinated at a 0,1 month interval (p = 0.037, 95% CI 1.03, 4.28). In vitro growth inhibition followed the antibody level: median inhibition was 51% (0,1 month interval) versus 85% (0,2 month interval) in antibody from samples taken 2 weeks post-second vaccination (p = 0.056).

AB - A Phase 1 study was conducted in 24 malaria naïve adults to assess the safety and immunogenicity of the recombinant protein vaccine apical membrane antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with CPG 7909 in two different formulations (phosphate buffer and saline), and given at two different dosing schedules, 0 and 1 month or 0 and 2 months. Both formulations were well tolerated and frequency of local reactions and solicited adverse events was similar among the groups. Peak antibody levels in the groups receiving CPG 7909 in saline were not significantly different than those receiving CPG 7909 in phosphate. Peak antibody levels in the groups vaccinated at a 0,2 month interval were 2.52-fold higher than those vaccinated at a 0,1 month interval (p = 0.037, 95% CI 1.03, 4.28). In vitro growth inhibition followed the antibody level: median inhibition was 51% (0,1 month interval) versus 85% (0,2 month interval) in antibody from samples taken 2 weeks post-second vaccination (p = 0.056).

KW - Apical membrane antigen 1

KW - Falciparum

KW - Malaria

UR - http://www.scopus.com/inward/record.url?scp=67349224673&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67349224673&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2009.04.077

DO - 10.1016/j.vaccine.2009.04.077

M3 - Article

C2 - 19410624

AN - SCOPUS:67349224673

VL - 27

SP - 4104

EP - 4109

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 31

ER -