GlaxoSmithKline has been boosted by the publication of two studies which reveal that “the world’s most clinically advanced malaria vaccine candidate” provides both infants and young children with significant protection against the disease.
Two Phase II trials, which have been published in the New England Journal of Medicine, have reaffirmed earlier study results and support plans, pending regulatory approvals, to launch a Phase III study of GSK’s RTS,S/AS vaccine candidate across Africa early next year.
The first study involved 894 children between the ages of 5 and 17 months in Kenya and Tanzania who were randomised to receive either three doses of RTS,S/AS01 or a rabies vaccine. The data showed that RTS,S/AS01 reduced malaria episodes by 53% for up to an average of eight months compared with the rabies jab.
In the other trial, 340 infants in Tanzania were administered either the RTS,S/AS02 formulation of the malaria vaccine or the hepatitis B vaccine at 8, 12 and 16 weeks of age along with a routine inoculation against diphtheria, tetanus, pertussis and influenza B. Findings showed that vaccination with RTS,S/AS02 led to a 65% reduction against first infection from malaria among children who received three doses and who were followed over a six-month period.
GSK and the PATH Malaria Vaccine Initiative (MVI) signed a public-private partnership agreement in 2001 to develop RTS,S/AS in Africa. The vaccine was invented, developed and manufactured at GSK Biologicals’ headquarters in Belgium in the late 1980s and initially tested in US volunteers.
Funding was made possible through a $107.6 million grant from the Bill & Melinda Gates Foundation and GSK has invested $300 million to date; another $50-100 million before the completion of the project.
Christian Loucq, MVI director, said the data “strongly show that our investments in developing malaria vaccines are beginning to pay dividends”. He added that “we are closer than ever before to developing a malaria vaccine for children in Africa”.
FDA approves GSK’s Boostrix for adults
Meantime, US regulators have expanded approval for GSK’s Boostrix vaccine against tetanus, diphtheria and pertussis (whooping cough) to include use in adults aged 19 to 64.
The jab was previously approved for use as a booster for adolescents and pre-adolescents aged 10 to 18. GSK noted that the FDA thumbs-up was based on data from two trials involving 3,000 subjects aged 19 to 64 who received the vaccine.
The company added that the approval means Boostrix now has the broadest age range for any Tdap vaccine.
