Safety and Immunogenicity of the Synthetic Malaria Vaccine SPf66 in a Large Field Trial

Amador, Roberto; Moreno, Alberto; Murillo, Luis A.; Sierra, Oscar; Saavedra, David; Rojas, Mauricio; Mora, Ana L.; Rocha, Claudia; Alvarado, Fernando; Falla, Juan Carlos; Orozco, Mauricio; Coronell, Carlos; Ortega, N.M.; Molano, Alberto; Velásquez, José Fernando; Valero, M.V.; Franco, Leticia Sánchez; Guzmán, Fanny; Salazar, Luz Mary; Espejo, Fabiola; Mora, Elsa; Farfán, Rocío; Zapata, Nohora; Rosas, Juan M.; Calvo, Julio C.; Castro, Jaime; Quiñones, Teódulo; Nuñez, F.; Patarroyo, Manuel E.

doi:10.1093/infdis/166.1.139

Cited by 55 publications

(10 citation statements)

References 18 publications

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“…Most studies have examined it adjuvanted with aluminum hydroxide. It showed mild protective efficacy in a South American and a Tanzanian study, but failed to show any benefit in the studies conducted in Gambia or Thailand 209 , 210 , 211 , 212 , 213 , 214 , 215 , 216 , 217 . Much controversy surrounded these studies and it was the subject of a Cochrane review, which concluded that there was no justification for further trials using the same formulation 218 …”

Section: Potential Targets and Their Prioritizationmentioning

confidence: 99%

The future for blood‐stage vaccines against malaria

2009

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Malaria is a leading cause of mortality and morbidity globally, and effective vaccines are urgently needed. Malaria vaccine approaches can be broadly grouped as pre-erythrocytic, blood stage and transmission blocking. This review focuses on bloodstage vaccines, and considers the evidence supporting the development of blood-stage vaccines, the advantages and challenges of this approach, potential targets, human vaccine studies and future directions. There is a strong rationale for the development of vaccines based on antigens of blood-stage parasites. Symptomatic malaria is caused by blood-stage parasitemia and acquired immunity in humans largely targets blood-stage antigens. Several candidate vaccines have proved efficacious in animal models and at least one vaccine showed partial efficacy in a clinical trial. At present, all leading candidate blood-stage antigens are merozoite proteins, located on the merozoite surface or within the apical organelles. Major challenges and priorities include overcoming antigenic diversity, identification of protective epitopes, understanding the nature and targets of protective immune responses, and defining antigen combinations that give the greatest efficacy. Additionally, objective criteria and approaches are needed to prioritize the large number of candidate antigens, and strong candidates need to be tested in clinical trials as quickly as possible.

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Section: Potential Targets and Their Prioritizationmentioning

confidence: 99%

The future for blood‐stage vaccines against malaria

2009

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“…Prospective, open, field trial, n = 15351; Local inflammation: erythema, induration or both: Amador 26 Safety data available for 5,117 M, 4,840 F. F > M in group aged 1-14 yrs and >14 yrs. Age range 1-14 yrs who received third dose of vaccine.…”

Section: Malaria Vaccine Spf66mentioning

confidence: 99%

Sex differences in injection site reactions with human vaccines

Cook¹

2009

Human Vaccines

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“…We have provided evidence that the synthetic peptide vaccine SPf66 is safe when administered to very young infants. Previous studies have shown it to be safe in a number of different epidemiological settings and in different age groups ( Amador et al . 1992a, b ; Patarroyo et al .…”

Section: Discussionmentioning

confidence: 99%

Safety in infants of SPf66, a synthetic malaria vaccine, delivered alongside the EPI

Schellenberg

Acosta

Galindo

et al. 1999

Tropical Med Int Health

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SummaryThe most likely mechanism to deliver a malaria vaccine in African countries is through the Expanded Program of Immunization (EPI). So far only SPf66, a multistage synthetic peptide, has shown any evidence of protection in Phase III field trials. In Tanzania, SPf66 reduced the risk of clinical malaria by 31% in children aged 1-5 years. In order to progress in the critical path of vaccine development and testing towards the implementation of a new vaccine in malaria control programs, we carried out a randomized double-blind placebo controlled efficacy trial of SPf66 when given alongside the EPI scheme. Monitoring of safety and reactogenicity during this trial included detailed clinical and laboratory assessments on 98 infants and assessment of adverse effects within 1 h of vaccination for all 1207 children vaccinated. Surveillance systems monitored attendances as outpatients, admissions to hospital and fatal events in the community. No serious adverse effects were detected more frequently amongst SPf66 recipients compared to placebo. This first assessment in very young infants of a synthetic vaccine provides evidence of a good safety profile.

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Safety and Immunogenicity of the Synthetic Malaria Vaccine SPf66 in a Large Field Trial

Cited by 55 publications

References 18 publications

The future for blood‐stage vaccines against malaria

The future for blood‐stage vaccines against malaria

Sex differences in injection site reactions with human vaccines

Safety in infants of SPf66, a synthetic malaria vaccine, delivered alongside the EPI

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