Abstract
Background. The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/ AS02A in adults exposed to seasonal malaria. Methodology/Principal Findings. A phase 1 double Wind randomized controlled dose escalation trial was conductected in Bandiagara, Mall, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 μg/A502A 0.25 ml. or FMP2.1 50 μg/AS02a 0.5 ml) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Sewious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and p. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-foid higher than baseline in the half-dose and full-dose groups, respectively. Conclusion/Significance. The FMP2.1/AS02A vaccine had a good safety profile, was well-talerated, and was highly immunogenic in malaria-exposed adults, This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site.
| Original language | English |
|---|---|
| Article number | e1465 |
| Pages (from-to) | 1-11 |
| Number of pages | 11 |
| Journal | PLoS One |
| Volume | 3 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2008 |
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Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults : Results of a phase 1 randomized controlled trial. / Thera, Mahamadou A.; Doumbo, Ogobara K.; Coulibaly, Drissa; Diallo, Dapa A.; Kone, Abdoulaye K.; Guindo, Ando B.; Traore, Karim; Dicko, Alassane; Sagara, Issaka; Sissoko, Mahamadou S.; Baby, Mounirou; Sissoko, Mady; Diarra, Issa; Niangaly, Amadou; Dolo, Amagana; Daou, Modibo; Diawara, Sory I.; Heppner, D. Gray; Stewart, V. Ann; Angov, Evelina; Bergmann-Leitner, Elke S.; Lanar, David E.; Dutta, Sheetij; Soisson, Lorraine; Diggs, Carter L.; Leach, Amanda; Owusu, Alex; Dubois, Marie Claude; Cohen, Joe; Nixon, Jason N.; Gregson, Aric; Takala, Shannon L.; Lyke, Kirsten E.; Plowe, Christopher V.
In: PLoS One, Vol. 3, No. 1, e1465, 2008, p. 1-11.Research output: Contribution to journal › Article › Research › peer-review
TY - JOUR
T1 - Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults
T2 - Results of a phase 1 randomized controlled trial
AU - Thera, Mahamadou A.
AU - Doumbo, Ogobara K.
AU - Coulibaly, Drissa
AU - Diallo, Dapa A.
AU - Kone, Abdoulaye K.
AU - Guindo, Ando B.
AU - Traore, Karim
AU - Dicko, Alassane
AU - Sagara, Issaka
AU - Sissoko, Mahamadou S.
AU - Baby, Mounirou
AU - Sissoko, Mady
AU - Diarra, Issa
AU - Niangaly, Amadou
AU - Dolo, Amagana
AU - Daou, Modibo
AU - Diawara, Sory I.
AU - Heppner, D. Gray
AU - Stewart, V. Ann
AU - Angov, Evelina
AU - Bergmann-Leitner, Elke S.
AU - Lanar, David E.
AU - Dutta, Sheetij
AU - Soisson, Lorraine
AU - Diggs, Carter L.
AU - Leach, Amanda
AU - Owusu, Alex
AU - Dubois, Marie Claude
AU - Cohen, Joe
AU - Nixon, Jason N.
AU - Gregson, Aric
AU - Takala, Shannon L.
AU - Lyke, Kirsten E.
AU - Plowe, Christopher V.
PY - 2008
Y1 - 2008
N2 - Background. The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/ AS02A in adults exposed to seasonal malaria. Methodology/Principal Findings. A phase 1 double Wind randomized controlled dose escalation trial was conductected in Bandiagara, Mall, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 μg/A502A 0.25 ml. or FMP2.1 50 μg/AS02a 0.5 ml) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Sewious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and p. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-foid higher than baseline in the half-dose and full-dose groups, respectively. Conclusion/Significance. The FMP2.1/AS02A vaccine had a good safety profile, was well-talerated, and was highly immunogenic in malaria-exposed adults, This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site.
AB - Background. The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/ AS02A in adults exposed to seasonal malaria. Methodology/Principal Findings. A phase 1 double Wind randomized controlled dose escalation trial was conductected in Bandiagara, Mall, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 μg/A502A 0.25 ml. or FMP2.1 50 μg/AS02a 0.5 ml) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Sewious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and p. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-foid higher than baseline in the half-dose and full-dose groups, respectively. Conclusion/Significance. The FMP2.1/AS02A vaccine had a good safety profile, was well-talerated, and was highly immunogenic in malaria-exposed adults, This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site.
UR - http://www.scopus.com/inward/record.url?scp=44849126049&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0001465
DO - 10.1371/journal.pone.0001465
M3 - Article
VL - 3
SP - 1
EP - 11
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 1
M1 - e1465
ER -