Limits...
Safety and allele-specific immunogenicity of a malaria vaccine in Malian adults: results of a phase I randomized trial.

Thera MA, Doumbo OK, Coulibaly D, Diallo DA, Sagara I, Dicko A, Diemert DJ, Heppner DG, Stewart VA, Angov E, Soisson L, Leach A, Tucker K, Lyke KE, Plowe CV, Mali FMP1 Working Gro - PLoS Clin Trials (2006)

Bottom Line: Solicited and unsolicited adverse events and allele-specific antibody responses to recombinant MSP-1(42) and its subunits derived from P. falciparum strains homologous and heterologous to the 3D7 vaccine strain were measured.Immunization with the malaria vaccine was followed by significant increases in antibodies recognizing three diverse MSP-1(42) alleles and their subunits.Anti-MSP-1(42) antibody levels followed a seasonal pattern that was significantly augmented and prolonged by the malaria vaccine.

View Article: PubMed Central - PubMed

Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali.

ABSTRACT

Objectives: The objectives were to evaluate the safety, reactogenicity, and allele-specific immunogenicity of the blood-stage malaria vaccine FMP1/AS02A in adults exposed to seasonal malaria and the impact of natural infection on vaccine-induced antibody levels.

Design: We conducted a randomized, double-blind, controlled phase I clinical trial.

Setting: Bandiagara, Mali, West Africa, is a rural town with intense seasonal transmission of Plasmodium falciparum malaria.

Participants: Forty healthy, malaria-experienced Malian adults aged 18-55 y were enrolled.

Interventions: The FMP1/AS02A malaria vaccine is a 42-kDa recombinant protein based on the carboxy-terminal end of merozoite surface protein-1 (MSP-1(42)) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The control vaccine was a killed rabies virus vaccine (Imovax). Participants were randomized to receive either FMP1/AS02A or rabies vaccine at 0, 1, and 2 mo and were followed for 1 y.

Outcome measures: Solicited and unsolicited adverse events and allele-specific antibody responses to recombinant MSP-1(42) and its subunits derived from P. falciparum strains homologous and heterologous to the 3D7 vaccine strain were measured.

Results: Transient local pain and swelling were more common in the malaria vaccine group than in the control group (11/20 versus 3/20 and 10/20 versus 6/20, respectively). MSP-1(42) antibody levels rose during the malaria transmission season in the control group, but were significantly higher in malaria vaccine recipients after the second immunization and remained higher after the third immunization relative both to baseline and to the control group. Immunization with the malaria vaccine was followed by significant increases in antibodies recognizing three diverse MSP-1(42) alleles and their subunits.

Conclusions: FMP1/AS02A was well tolerated and highly immunogenic in adults exposed to intense seasonal malaria transmission and elicited immune responses to genetically diverse parasite clones. Anti-MSP-1(42) antibody levels followed a seasonal pattern that was significantly augmented and prolonged by the malaria vaccine.

No MeSH data available.


Related in: MedlinePlus

Trial Profile
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC1851722&req=5

pctr-0010034-g001: Trial Profile

Mentions: Of 108 screened adults, 40 were deemed eligible and enrolled in July 2003 (Figure 1). The main reasons for exclusion were concurrent illnesses and intent to travel during the trial. The two vaccine groups did not differ significantly at enrollment with regard to sex, age, or laboratory parameters (Table 1). Seven participants were female. The mean age was 39 y. All participants received all three immunizations according to the 0-, 1-, and 2-mo schedule. All participants completed all scheduled visits and were included in the analysis.


Safety and allele-specific immunogenicity of a malaria vaccine in Malian adults: results of a phase I randomized trial.

Thera MA, Doumbo OK, Coulibaly D, Diallo DA, Sagara I, Dicko A, Diemert DJ, Heppner DG, Stewart VA, Angov E, Soisson L, Leach A, Tucker K, Lyke KE, Plowe CV, Mali FMP1 Working Gro - PLoS Clin Trials (2006)

Trial Profile
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC1851722&req=5

pctr-0010034-g001: Trial Profile
Mentions: Of 108 screened adults, 40 were deemed eligible and enrolled in July 2003 (Figure 1). The main reasons for exclusion were concurrent illnesses and intent to travel during the trial. The two vaccine groups did not differ significantly at enrollment with regard to sex, age, or laboratory parameters (Table 1). Seven participants were female. The mean age was 39 y. All participants received all three immunizations according to the 0-, 1-, and 2-mo schedule. All participants completed all scheduled visits and were included in the analysis.

Bottom Line: Solicited and unsolicited adverse events and allele-specific antibody responses to recombinant MSP-1(42) and its subunits derived from P. falciparum strains homologous and heterologous to the 3D7 vaccine strain were measured.Immunization with the malaria vaccine was followed by significant increases in antibodies recognizing three diverse MSP-1(42) alleles and their subunits.Anti-MSP-1(42) antibody levels followed a seasonal pattern that was significantly augmented and prolonged by the malaria vaccine.

View Article: PubMed Central - PubMed

Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali.

ABSTRACT

Objectives: The objectives were to evaluate the safety, reactogenicity, and allele-specific immunogenicity of the blood-stage malaria vaccine FMP1/AS02A in adults exposed to seasonal malaria and the impact of natural infection on vaccine-induced antibody levels.

Design: We conducted a randomized, double-blind, controlled phase I clinical trial.

Setting: Bandiagara, Mali, West Africa, is a rural town with intense seasonal transmission of Plasmodium falciparum malaria.

Participants: Forty healthy, malaria-experienced Malian adults aged 18-55 y were enrolled.

Interventions: The FMP1/AS02A malaria vaccine is a 42-kDa recombinant protein based on the carboxy-terminal end of merozoite surface protein-1 (MSP-1(42)) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The control vaccine was a killed rabies virus vaccine (Imovax). Participants were randomized to receive either FMP1/AS02A or rabies vaccine at 0, 1, and 2 mo and were followed for 1 y.

Outcome measures: Solicited and unsolicited adverse events and allele-specific antibody responses to recombinant MSP-1(42) and its subunits derived from P. falciparum strains homologous and heterologous to the 3D7 vaccine strain were measured.

Results: Transient local pain and swelling were more common in the malaria vaccine group than in the control group (11/20 versus 3/20 and 10/20 versus 6/20, respectively). MSP-1(42) antibody levels rose during the malaria transmission season in the control group, but were significantly higher in malaria vaccine recipients after the second immunization and remained higher after the third immunization relative both to baseline and to the control group. Immunization with the malaria vaccine was followed by significant increases in antibodies recognizing three diverse MSP-1(42) alleles and their subunits.

Conclusions: FMP1/AS02A was well tolerated and highly immunogenic in adults exposed to intense seasonal malaria transmission and elicited immune responses to genetically diverse parasite clones. Anti-MSP-1(42) antibody levels followed a seasonal pattern that was significantly augmented and prolonged by the malaria vaccine.

No MeSH data available.


Related in: MedlinePlus