In NIH-funded trials, malaria vaccine candidate offers long-lasting protection

In NIH-funded trials, malaria vaccine candidate offers long-lasting protection

August 15, 2024

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Tuesday August 14, 2024

This approach could play a role in preventing malaria during pregnancy.

Photomontage of infected blood cells, mosquitoes and vaccine vials.

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The National Institutes of Health supported two trials of an experimental malaria vaccine in healthy adult volunteers from Mali. All three regimens tested were safe. In one study, 300 healthy women ages 18 to 38 who were expected to become pregnant shortly after vaccination participated. The trial began with a drug to kill malaria parasites. Three injections were then given over a one-month period, either with saline or with a two-dose experimental vaccine. The vaccine candidate was effective in protecting against parasite infection and malaria for two years, without the need for a booster dose. It is the first malaria vaccine to do so. An exploratory study of pregnant women who conceived during the study period showed that the vaccine protected pregnant women from malaria. The approach used in the study, if confirmed by additional clinical trials and validated by further research, could lead to better methods of preventing malaria during pregnancy.

Spread the word Anopheles Mosquitoes and malaria parasites, including species Plasmodium falciparum (Pf(can cause illness in anyone of any age. However, the most vulnerable are pregnant women, babies and young children. In Africa, malaria parasitaemia during pregnancy can cause up to 50,000 deaths in women and 200,000 stillbirths each year.

Researchers from the NIH's National Institute of Allergy and Infectious Diseases in Bamako and the University of Science, Techniques, and Technology of Bamako in Mali co-led the trials. Both trials used the radiation-attenuated PfSPZ vaccine. Pf Sanaria Inc. of Rockville, Maryland, manufactures sporozoites, a phase of the parasite’s life cycle. The PfSPZ vaccine has been shown to be safe in numerous clinical trials, even those conducted in countries with high malaria rates such as Mali. Results from a NIAID-sponsored placebo-controlled trial in Burkina Faso in 2022 showed that the PfSPZ vaccine had an efficacy of 46 % for at least 18 months.

55 women became pregnant during the first year after the third dose of vaccine. The vaccine efficacy against parasitemia was 86 % for women who received the high dose and 65 % for those who took the low dose. In 155 women who became pregnant during the two years of the study, 57 % of those who received the low dose vaccine were protected and 49 % of those who received the high dose.

The researchers reported that women who received either the experimental vaccine or placebo conceived earlier than the placebo group, but this result did not reach statistical significance. The researchers hypothesized that the PfSPZ vaccine may prevent malaria-related miscarriages because the risks of parasitemia during the periconception phase were reduced by 65 to 86 %.

The researchers note that “preconception vaccination is a novel strategy to reduce mortality in women with malaria during pregnancy.” The researchers plan to examine the safety of PfSPZ administered during pregnancy and then assess the effectiveness of PfSPZ administered before conception or during pregnancy. They added that “existing measures do not protect women from malaria during pregnancy.” They conclude that “safe and effective vaccination is urgently needed, and we believe that the PfSPZ vaccine may be a good candidate.”

Dr. Alassane Dicko was the PfSPZ vaccine team leader. He worked with Dr. Stephen L. Hoffman of Sanaria Inc. and Dr. Patrick E. Duffy of the NIAID Malaria Vaccinology and Immunology Laboratory. Dr. Halimatou Diawara of MRTC and Dr. Sara A. Healy of NIAID were co-first authors.

You can find more information about the trial at clinicaltrials.gov Use the credentials NCT03510481 You can also learn more about NCT03989102.

The article below provides more information about the item.

H Diawara The et all Two randomized, controlled, double-blind, phase 1 and 2, placebo-controlled trials in Mali to evaluate the safety and efficacy of PfSPZ malaria vaccine in healthy adults and pregnant women.. Lancet Infectious diseases DOI: 10.1016/S1473-3099(24)00360-8 (2024).

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Patrick E. Duffy, MD, is chief of the Malaria Immunology and Vaccinology Branch at NIAID. He can be contacted for comment.

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The National Institutes of Health: The NIH is the medical research agency of the U.S. Department of Health and Human Services. It is comprised of 27 institutes and centers. The NIH, the nation's medical research agency, is comprised of 27 institutes and centers and is part of the U.S. Department of Health and Human Services. Visit the NIH for more information about its programs. www.nih.gov.

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