Research Article: Randomized Controlled Field Trial to Assess the Immunogenicity and Safety of Rift Valley Fever Clone 13 Vaccine in Livestock

Date Published: March 10, 2015

Publisher: Public Library of Science

Author(s): M. Kariuki Njenga, Leonard Njagi, S. Mwangi Thumbi, Samuel Kahariri, Jane Githinji, Eunice Omondi, Amy Baden, Mbabu Murithi, Janusz Paweska, Peter M. Ithondeka, Kisa J. Ngeiywa, Baptiste Dungu, Meritxell Donadeu, Peninah M. Munyua, Ernesto T. A. Marques.

Abstract: BackgroundAlthough livestock vaccination is effective in preventing Rift Valley fever (RVF) epidemics, there are concerns about safety and effectiveness of the only commercially available RVF Smithburn vaccine. We conducted a randomized controlled field trial to evaluate the immunogenicity and safety of the new RVF Clone 13 vaccine, recently registered in South Africa.MethodsIn a blinded randomized controlled field trial, 404 animals (85 cattle, 168 sheep, and 151 goats) in three farms in Kenya were divided into three groups. Group A included males and non-pregnant females that were randomized and assigned to two groups; one vaccinated with RVF Clone 13 and the other given placebo. Groups B included animals in 1st half of pregnancy, and group C animals in 2nd half of pregnancy, which were also randomized and either vaccinated and given placebo. Animals were monitored for one year and virus antibodies titers assessed on days 14, 28, 56, 183 and 365.ResultsIn vaccinated goats (N = 72), 72% developed anti-RVF virus IgM antibodies and 97% neutralizing IgG antibodies. In vaccinated sheep (N = 77), 84% developed IgM and 91% neutralizing IgG antibodies. Vaccinated cattle (N = 42) did not develop IgM antibodies but 67% developed neutralizing IgG antibodies. At day 14 post-vaccination, the odds of being seropositive for IgG in the vaccine group was 3.6 (95% CI, 1.5 – 9.2) in cattle, 90.0 (95% CI, 25.1 – 579.2) in goats, and 40.0 (95% CI, 16.5 – 110.5) in sheep. Abortion was observed in one vaccinated goat but histopathologic analysis did not indicate RVF virus infection. There was no evidence of teratogenicity in vaccinated or placebo animals.ConclusionsThe results suggest RVF Clone 13 vaccine is safe to use and has high (>90%) immunogenicity in sheep and goats but moderate (> 65%) immunogenicity in cattle.

Partial Text: Rift Valley fever (RVF) is an acute disease that is caused by a phlebovirus of the Bunyaviridae family of viruses that affects livestock (cattle, sheep, goats, camels) and humans in Africa and the Arabian Peninsula [1–3]. In Africa, periodic and severe epidemics have been reported in Kenya, Somalia, Tanzania, Sudan, South Africa, Zimbabwe, Senegal, Mauritania, Egypt, and Madagascar [2,4–8]. Even though determining the actual morbidity and mortality in humans has been difficult, an RVF epidemic in Egypt in 1977 resulted in an estimated 200,000 human cases and 600 deaths whereas the one in East Africa (Kenya, Somalia, Tanzania) in 1997–98 resulted in over 100,000 cases and over 450 deaths in Kenya alone [4,9–11]. The RVF epidemic in Saudi Arabia and Yemen in 2002 resulted in an estimated 4000 human cases and over 200 deaths [2,3].

Although the need for a better RVF livestock vaccine has been recognized for many years, the efforts to generate and manufacture one have been slow and difficult. This is perhaps because of the limited market, which is primarily in Africa, and the fact that RVF cases and epidemics can sometimes be absent for over 10 years even in endemic countries. As a prevention and control measure, livestock vaccination should be used in the context of a national strategy guided by a risk-based analysis [20]. Whether the strategy includes structured regular vaccinations to prevent the disease or immediate action to prevent an imminent outbreak, livestock vaccination needs to be systematic and thorough, targeting all high risk regions in a country and accompanied by other important measures such as monitoring and evaluation to determine coverage and sentinel surveillance (Munyua et al., IN PRESS). The explosive and sequential nature of RVF outbreaks in sub-Saharan Africa has often meant that when an early warning for the disease is issued, even in the presence of adequate resources, there are inadequate vaccine reserves globally to cover livestock at risk in one country, leave alone in multiple countries. To mitigate this risk, the idea of creating a shared vaccine bank consisting of epidemic—prone countries has been discussed but never implemented.



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