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Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants
Salim Abdulla1, Rolf Oberholzer, Omar Juma
1Bagamoyo Research and Training Centre of Ifakara Health Institute, Bagamoyo, Tanzania. sabdulla@ihi.or.tz
Insights
The RTS,S/AS02D malaria vaccine showed a good safety profile in infants and did not affect immune responses to routine vaccines. This malaria vaccine candidate demonstrated significant efficacy in preventing Plasmodium falciparum infection.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- The RTS,S/AS malaria vaccine is under development for integration into the World Health Organization's Expanded Program on Immunization (EPI).
- Assessing the feasibility of incorporating the RTS,S/AS02D vaccine into standard infant immunization schedules is crucial for public health initiatives.
Purpose of the Study:
- To evaluate the safety and immunogenicity of the RTS,S/AS02D malaria vaccine when coadministered with standard EPI vaccines in infants.
- To determine the efficacy of the RTS,S/AS02D vaccine against Plasmodium falciparum malaria infection.
Main Methods:
- A phase 2B, single-center, double-blind, controlled trial was conducted in 340 infants in Tanzania.
- Infants received three doses of either RTS,S/AS02D or hepatitis B vaccine, alongside a DTPw/Hib vaccine.
- Primary objectives included safety surveillance and noninferiority of immune responses to EPI antigens; secondary objectives focused on anti-circumsporozoite antibody detection and malaria efficacy.
Main Results:
- The RTS,S/AS02D vaccine exhibited a comparable safety profile to the hepatitis B vaccine, with lower rates of serious adverse events.
- Noninferiority of immune responses to coadministered EPI vaccines (DTPw/Hib and hepatitis B) was demonstrated.
- High seropositivity for anti-circumsporozoite antibodies (98.6%) was observed one month post-vaccination, and vaccine efficacy against P. falciparum malaria infection was 65.2% during the 6-month follow-up period.
Conclusions:
- The RTS,S/AS02D vaccine presents a promising safety profile for infant immunization programs.
- Coadministration of RTS,S/AS02D with EPI vaccines did not compromise immune responses to routine antigens.
- The RTS,S/AS02D vaccine significantly reduced the incidence of malaria infection in infants, highlighting its potential as a malaria prevention tool.
Background:
The RTS,S/AS malaria vaccine is being developed for delivery through the World Health Organization's Expanded Program on Immunization (EPI). We assessed the feasibility of integrating RTS,S/AS02D into a standard EPI schedule for infants.
Methods:
In this phase 2B, single-center, double-blind, controlled trial involving 340 infants in Bagamoyo, Tanzania, we randomly assigned 340 infants to receive three doses of either the RTS,S/AS02D vaccine or the hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received a vaccine containing diphtheria and tetanus toxoids, whole-cell pertussis vaccine, and conjugated Haemophilus influenzae type b vaccine (DTPw/Hib). The primary objectives were the occurrence of serious adverse events during a 9-month surveillance period and a demonstration of noninferiority of the responses to the EPI vaccines (DTPw/Hib and hepatitis B surface antigen) with coadministration of the RTS,S/AS02D vaccine, as compared with the hepatitis B vaccine. The detection of antibodies against Plasmodium falciparum circumsporozoite and efficacy against malaria infection were secondary objectives.
Results:
At least one serious adverse event was reported in 31 of 170 infants who received the RTS,S/AS02D vaccine (18.2%; 95% confidence interval [CI], 12.7 to 24.9) and in 42 of 170 infants who received the hepatitis B vaccine (24.7%; 95% CI, 18.4 to 31.9). The results showed the noninferiority of the RTS,S/AS02D vaccine in terms of antibody responses to EPI antigens. One month after vaccination, 98.6% of infants receiving the RTS,S/AS02D vaccine had seropositive titers for anticircumsporozoite antibodies on enzyme-linked immunosorbent assay (ELISA). During the 6-month period after the third dose of vaccine, the efficacy of the RTS,S/AS02D vaccine against first infection with P. falciparum malaria was 65.2% (95% CI, 20.7 to 84.7; P=0.01).
Conclusions:
The use of the RTS,S/AS02D vaccine in infants had a promising safety profile, did not interfere with the immunologic responses to coadministered EPI antigens, and reduced the incidence of malaria infection. (ClinicalTrials.gov number, NCT00289185.)
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