Safety and immunogenicity of a recombinant tetravalent dengue vaccine in 9-16 year olds: a randomized, controlled, phase II trial in Latin America.

Abstract

BACKGROUND:

The dengue virus is a member of the Flavivirus (FV) genus, which also includes the yellow fever virus. Dengue disease is caused by any 1 of 4 dengue virus serotypes and is a serious public health concern in Latin America. This study evaluated the safety and immunogenicity of a candidate recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in 9-16 year olds in Latin America.

METHODS:

In this randomized, blinded, controlled study, volunteers received either 3 doses of CYD-TDV (n = 401) or placebo as first and second injection and tetanus/diphtheria/acellular pertussis vaccine as third injection (n = 199) at 0, 6 and 12 months. Adverse events were documented. Plaque reduction neutralization test antibody titers against the 4 CYD-TDV parental strains were measured before and 28 days after each dose. Seropositivity was defined as antibody titers ≥10 1/dil.

RESULTS:

The number of adverse reactions decreased after each successive CYD-TDV dose. After each CYD-TDV dose, antibody titers against all 4 serotypes were higher than baseline and respective predose titers. After the third dose of CYD-TDV, 100%, 98.6% and 93.4% of participants were seropositive for at least 2, at least 3 or all 4 serotypes, respectively. Higher antibody titers were observed in participants in the CYD-TDV group who were FV-seropositive at baseline compared with those who were FV-seronegative.

CONCLUSIONS:

CYD-TDV had a favorable safety profile and elicited antibody responses against all 4 dengue virus serotypes in 9-16 year olds in Latin America. These findings support the continued development of CYD-TDV.

• Authors: Luis Á Villar, Doris M Rivera-Medina, José Luis Arredondo-García, Mark Boaz, Linda Starr-Spires, Manoj Thakur, Betzana Zambrano, María C Miranda, Enrique Rivas, Gustavo H Dayan
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 32 Issue 10 Pg. 1102-9 (Oct 2013) ISSN: 1532-0987 [Electronic] United States
• PMID: 24067553 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Viral
• Dengue Vaccines
• Vaccines, Synthetic

Topics

• Adolescent
• Antibodies, Viral (blood)
• Child
• Dengue (immunology, prevention & control)
• Dengue Vaccines (administration & dosage, adverse effects, immunology)
• Female
• Humans
• Latin America
• Male
• Single-Blind Method
• Vaccines, Synthetic (administration & dosage, adverse effects, immunology)