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Prospective human trials with Dengue virus vaccines and the NS1 antigen production among vaccine recipients

There has been phenomenal progress toward development of effective vaccines against dengue virus employing live attenuated vaccines, recombinant virus vectors, recombinant proteins and DNA vaccines. Irrespective of the technology employed for candidate vaccine lots, their genetic stability, phenotypic stability, and immunogenicity including viremia would have to be excellent. Consequently, with every phase I, II and III clinical trial, safety, humoral immunity, cellular immune responses including cytokine profile, CD8/Th bias, serotype dominance, recombination, and reversion to virulence including any transmission to vectors should be scrutinized meticulously. To our knowledge, the production of the dengue virus non-structural protein, NS1, in recipients of candidate dengue vaccines has not been monitored in any clinical trial. The kinetics of NS1 antigen production and duration of its persistence in vaccinees would be important to follow. Such data would guide clinicians treating vaccinees who might be afflicted with dengue virus infection after receiving tetravalent or other dengue vaccines. Obviously, suspected patients in areas where dengue vaccines were offered regularly, if tested positive for NS1 antigen, would have to differentiate between those with an NS1 antigen-positive reaction attributable to a fresh viral infection or persistent NS1 antigen following prior dengue vaccination. In conclusion, kinetics of NS1 antigen production among recipients of dengue vaccines would be helpful in the diagnosis of dengue virus infection in the vaccination era.