PMID- 17207146
OWN - NLM
STAT- MEDLINE
DCOM- 20070315
LR  - 20220427
IS  - 1360-2276 (Print)
IS  - 1360-2276 (Linking)
VI  - 12
IP  - 1
DP  - 2007 Jan
TI  - Safety and immunogenicity of the RTS,S/AS02A candidate malaria vaccine in 
      children aged 1-4 in Mozambique.
PG  - 37-46
AB  - BACKGROUND: The development of a malaria vaccine remains a public health priority 
      for sub-Saharan Africa. RTS,S/AS02A candidate malaria vaccine has been shown to 
      be safe and immunogenic in previous studies in adults and staggered 
      dose-escalation studies in children in The Gambia. However, genetic features and 
      the intensity of malaria transmission may modify the safety and immune response 
      of a vaccine. OBJECTIVE: We carried out a phase I, double-blind randomized 
      controlled trial in 60 children aged 1-4 in Mozambique to evaluate the safety, 
      reactogenicity and immunogenicity of the paediatric vaccine dose (fixed 25 microg 
      RTS,S in 0.25 ml) of RTS,S/AS02A, prior to undertaking a planned larger phase IIb 
      proof-of-concept of efficacy study in the same population. METHOD: Children were 
      randomized to receive either RTS,S/AS02A or Engerix-B vaccine. Monitoring of 
      safety and reactogenicity included detailed clinical and laboratory analyses and 
      assessment of adverse events (AEs). RESULTS: The RTS,S/AS02A was found to be safe 
      and well tolerated. Serious adverse events were balanced between both groups and 
      none was related to vaccination. The frequency of adverse events reported with 
      RTS, S/AS02A was comparable to previous studies in children. Grade 3 AEs were 
      infrequent (one case of pain, one of fever in each group and some swelling 
      greater than 20 mm in diameter), transient and resolved without sequelae. 
      RTS,S/AS02A was highly immunogenic for anti-circumsporozoite protein antibody 
      response and induced a strong anti-hepatitis-B surface antigen response.
FAU - Macete, E
AU  - Macete E
AD  - Centro de Investigacao em Saude da Manhica (CISM), Manhica, Mozambique.
FAU - Aponte, J J
AU  - Aponte JJ
FAU - Guinovart, C
AU  - Guinovart C
FAU - Sacarlal, J
AU  - Sacarlal J
FAU - Ofori-Anyinam, O
AU  - Ofori-Anyinam O
FAU - Mandomando, I
AU  - Mandomando I
FAU - Espasa, M
AU  - Espasa M
FAU - Bevilacqua, C
AU  - Bevilacqua C
FAU - Leach, A
AU  - Leach A
FAU - Dubois, M C
AU  - Dubois MC
FAU - Heppner, D G
AU  - Heppner DG
FAU - Tello, L
AU  - Tello L
FAU - Milman, J
AU  - Milman J
FAU - Cohen, J
AU  - Cohen J
FAU - Dubovsky, F
AU  - Dubovsky F
FAU - Tornieporth, N
AU  - Tornieporth N
FAU - Thompson, R
AU  - Thompson R
FAU - Alonso, P L
AU  - Alonso PL
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Trop Med Int Health
JT  - Tropical medicine & international health : TM & IH
JID - 9610576
RN  - 0 (Antibodies, Protozoan)
RN  - 0 (Engerix-B)
RN  - 0 (Hepatitis B Surface Antigens)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Malaria Vaccines)
RN  - 0 (Protozoan Proteins)
RN  - 0 (RTS,S-AS02A vaccine)
RN  - 0 (circumsporozoite protein, Protozoan)
RN  - AYI8EX34EU (Creatinine)
RN  - EC 2.6.1.2 (Alanine Transaminase)
SB  - IM
MH  - Alanine Transaminase/blood
MH  - Antibodies, Protozoan/immunology
MH  - Child, Preschool
MH  - Creatinine/blood
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Hepatitis/immunology
MH  - Hepatitis B Surface Antigens/immunology
MH  - Hepatitis B Vaccines/adverse effects/immunology
MH  - Humans
MH  - Infant
MH  - Injections/adverse effects
MH  - Malaria Vaccines/administration & dosage/adverse effects/*immunology
MH  - Malaria, Falciparum/epidemiology/immunology/prevention & control
MH  - Mozambique/epidemiology
MH  - Pain/chemically induced
MH  - Protozoan Proteins/immunology
EDAT- 2007/01/09 09:00
MHDA- 2007/03/16 09:00
CRDT- 2007/01/09 09:00
PHST- 2007/01/09 09:00 [pubmed]
PHST- 2007/03/16 09:00 [medline]
PHST- 2007/01/09 09:00 [entrez]
AID - TMI1754 [pii]
AID - 10.1111/j.1365-3156.2006.01754.x [doi]
PST - ppublish
SO  - Trop Med Int Health. 2007 Jan;12(1):37-46. doi: 10.1111/j.1365-3156.2006.01754.x.