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Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region

Abdulla, Salim, Salim, Nahya, Machera, Francisca, Kamata, Richard, Juma, Omar, Shomari, Mwanajaa, Kubhoja, Sulende, Mohammed, Ali, Mwangoka, Grace, Aebi, Thomas, Mshinda, Hassan, Schellenberg, David, Carter, Terrell, Villafana, Tonya, Dubois, Marie-Claude, Leach, Amanda J., Lievens, Marc, Vekemans, Johan, Cohen, Joe, Ballou, W. Ripley and et al. (2013). Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region. Malaria Journal,12:1-11.

Document type: Journal Article
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IRMA ID 75039815xPUB484
Title Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region
Author Abdulla, Salim
Salim, Nahya
Machera, Francisca
Kamata, Richard
Juma, Omar
Shomari, Mwanajaa
Kubhoja, Sulende
Mohammed, Ali
Mwangoka, Grace
Aebi, Thomas
Mshinda, Hassan
Schellenberg, David
Carter, Terrell
Villafana, Tonya
Dubois, Marie-Claude
Leach, Amanda J.
Lievens, Marc
Vekemans, Johan
Cohen, Joe
Ballou, W. Ripley
et al.
Journal Name Malaria Journal
Publication Date 2013
Volume Number 12
ISSN 1475-2875   (check CDU catalogue  open catalogue search in new window)
Scopus ID 2-s2.0-84871974252
Start Page 1
End Page 11
Total Pages 11
Place of Publication United Kingdom
Publisher BioMed Central
HERDC Category C1 - Journal Article (DIISR)
Abstract Background
The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02D vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up.

Methods
This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02D or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine) at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20.

Results
From month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02D (33.5%; 95% confidence interval [CI]: 26.5, 41.2) and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2). The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18 months after completion of vaccination, 71.8% of recipients of RTS,S/AS02D and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02D and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02D group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p = 0.072) and 26.7% (95% CI: -33.1 to 59.6, p = 0.307) over 12 and 18 months post vaccination, respectively. In the Intention to Treat population, over the 20-month follow up, vaccine efficacy against multiple episodes of malaria disease was 14.4% (95% CI: -41.9 to 48.4, p = 0.545).

Conclusions
The acceptable safety profile and good tolerability of RTS,S/AS02D in combination with EPI vaccines previously reported from month 0 to 9 was confirmed over a 20 month surveillance period in this infant population. Antibodies against both CS and HBsAg in the RTS,S/AS02D group remained significantly higher compared to control for the study duration. Over 18 months follow up, RTS,S/AS02D prevented approximately a quarter of malaria cases in the study population.

Clinical trials
Gov identifier: NCT00289185
Keywords RTS,S/AS02
Falciparum
Malaria
Infants
Immunogenicity
Safety
Efficacy
EPI
DOI http://dx.doi.org/10.1186/1475-2875-12-11   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
Additional Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License 2.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Description for Link Link to CC Attribution 2.0 License
URL https://creativecommons.org/licenses/by/2.0/


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