Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.
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Malkin Elissa, Zaric Marija, Kieh Mark, Baden Lindsey R, Fitz-Patrick David, Marini Arianna, Yun Heejin, Hayes Peter, Bromell Rachel, Ayorinde Morolayo, Fernandez Natalia, Varma Ruhani, Sigei Faith, Ward Matthew, Pindolia Hema, Sewell Shayna, Amini Fahimah, Blie Julie, Wilson Barthalomew, Faley Patrick, McCullough John, Tokpah Franklin, Wisseh Cecelia, Towalid Elvis, Hadawale Swapnil, Sayeed Eddy, Hunt Devin, Keshavarzi Nahid, Barin Burc, Maljkovic Berry Irina, Parks Christopher L, Truter Shobhna Gopal, Walker Kathleen, Vekemans Johan, Lehrman Jennifer, Engelbrecht Michelle, Malherbe Mariette, Laufer Dagna, Philiponis Vincent, Higgs Elizabeth, Mutua Gaudensia, Fast Patricia E, Gupta Swati B, rVSVΔG-LASV-GPC Study Group
Аннотация
METHODS: In this phase 1, double-blind trial conducted in the United States and Liberia, we randomly assigned healthy adults (18 to 50 years of age) to receive rVSVΔG-LASV-GPC or placebo intramuscularly. Participants received a single vaccine dose of 2×104 plaque-forming units (PFU), 2×105 PFU, 2×106 PFU, or 2×107 PFU or placebo or received two vaccine doses of 2×107 PFU or placebo, within a window of 6 to 20 weeks. The side-effect profile was assessed according to the incidence of solicited and unsolicited adverse events (primary end point). Because Lassa fever can cause sensorineural hearing loss, hearing acuity was measured before and after the injection. Secondary end points were levels of binding antibodies against LASV glycoprotein, neutralizing antibodies, and vaccine vector-derived viral RNA and PFU in plasma, urine, and saliva.
RESULTS: A total of 114 adults were enrolled. No serious vaccine-related adverse events were reported. The vaccine caused minimal local reactions and dose-dependent, mild-to-severe early-onset systemic reactogenicity events that were transient. No hearing loss was detected. All doses induced robust long-lasting cellular and humoral (binding and neutralizing) responses that cross-reacted against common LASV lineages. No infectious vaccine virus particles were found in plasma, urine, or saliva.
CONCLUSIONS: The rVSVΔG-LASV-GPC vaccine resulted in transient local and systemic reactogenicity events but no hearing loss or serious adverse events. The vaccine had immunogenicity over a wide dose range in healthy adults in the United States and Liberia. (Funded by the Coalition for Epidemic Preparedness Innovations and the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04794218; Pan African Clinical Trials Registry number, PACTR2021106625781067.).