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randomized trial

Not Open Access | Unanticipated CNS Safety Signal in a Placebo-controlled, Randomized Trial of Co-administered Atovaquone-Proguanil and Amodiaquine

September 1, 2021 - 15:48 -- NOT Open Access
Chalon S, Chughlay MF, Abla N, Tchouatieu AM, Haouala A, Hutter B, Lorch U, Macintyre F
Clin Pharmacol Ther. 2021 Aug 28

Atovaquone-proguanil (ATV-PG) plus amodiaquine (AQ) has been considered as a potential replacement for sulfadoxine-pyrimethamine plus AQ for seasonal malaria chemoprevention (SMC) in African children. This randomized, double-blind, placebo-controlled, parallel group study assessed the safety, tolerability, and pharmacokinetics (PK) of ATV-PG plus AQ in healthy adult males and females of Black sub-Saharan African origin.

Identifying prognostic factors of severe metabolic acidosis and uraemia in African children with severe falciparum malaria: a secondary analysis of a randomized trial

June 30, 2021 - 12:20 -- Open Access
Grace Mzumara, Stije Leopold, Kevin Marsh, Arjen Dondorp, Eric O. Ohuma and Mavuto Mukaka
Malaria Journal 2021 20:282, 25 June 2021

Severe metabolic acidosis and acute kidney injury are major causes of mortality in children with severe malaria but are often underdiagnosed in low resource settings.

Randomized trials of housing interventions to prevent malaria and Aedes-transmitted diseases: A systematic review and meta-analysis

January 13, 2021 - 11:28 -- Open Access
Kua KP, Lee SWH
PLoS One. 2021 Jan 8;16(1):e0244284

Mosquito-borne diseases remain a significant public health problem in tropical regions. Housing improvements such as screening of doors and windows may be effective in reducing disease transmission, but the impact remains unclear.

Estimation of the primary, secondary and composite effects of malaria vaccines using data on multiple clinical malaria episodes

June 17, 2020 - 12:49 -- Open Access
Cheung YB, Ma X, Lam KF, Milligan P
Vaccine. 2020 Jun 11:S0264-410X(20)30753-2

An effective malaria vaccine affects the risk of malaria directly, through the vaccine-induced immune response (the primary effect), and indirectly, as a consequence of reduced exposure to malaria infection and disease, leading to slower acquisition of natural immunity (the secondary effect). The beneficial primary effect may be offset by a negative secondary effect, resulting in a smaller or nil composite effect. Reports of malaria vaccine trials usually present only the composite effect. We aimed to demonstrate how the primary and secondary effects can also be estimated from trial data.

Long-term immunogenicity and immune memory response to the hepatitis B antigen in the RTS,S/AS01E malaria vaccine in African children: a randomized trial

January 24, 2020 - 15:04 -- Open Access
Valéa I, Adjei S, Agbenyega T, et al.
Hum Vaccin Immunother. 2020 Jan 17:1-7

RTS,S/AS01E malaria vaccine contains the hepatitis B virus surface antigen and may thus serve as a potential hepatitis B vaccine. To evaluate the impact of RTS,S/AS01E when implemented in the Expanded Program of Immunization, infants 8–12 weeks old were randomized to receive either RTS,S/AS01E or a licensed hepatitis B control vaccine (HepB), both co-administered with various combinations of the following childhood vaccines: diphtheria-tetanus-acellular pertussis-Haemophilus influenzae type b, trivalent oral poliovirus, pneumococcal non-typeable Haemophilus influenzae protein D conjugate and human rotavirus vaccine.

Safety and immunogenicity of the RTS,S/AS01 malaria vaccine in infants and children identified as HIV-infected during a randomized trial in sub-Saharan Africa

January 24, 2020 - 14:40 -- Open Access
Otieno L, Guerra Mendoza Y, Oneko M, et al.
Vaccine Volume 38, Issue 4, 22 January 2020, Pages 897-906

We assessed the safety and immunogenicity of the RTS,S/AS01 malaria vaccine in a subset of children identified as HIV-infected during a large phase III randomized controlled trial conducted in seven sub-Saharan African countries.

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