Effectiveness and safety of the Butantan-DV single-dose tetravalent vaccine against Dengue: real-world data after mass vaccination in the municipality of Botucatu

Mass vaccination for Dengue control in Botucatu: effectiveness and safety profile evaluation of the single-dose tetravalent vaccine Butantan-DV

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

REBEC

Registry ID

RBR-6tmdrtg

Enrollment

93892

Registered

2026-02-23

Start date

2026-01-19

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Dengue

Interventions

This is a hybrid surveillance study of effectiveness and safety. Following the intervention (mass vaccination in the municipality of Botucatu as a Ministry of Health strategy for dengue control – Buta

2) STUDY 2 - Test-Negative Case-Control Study: Recruitment will be based on the outcome (notification of a suspected dengue case), followed by a retrospective search for exposure (dengue vaccine) only

cases,&apos

while those discarded due to a negative test (collected within the appropriate timeframe for the disease) will be the &apos

controls.

3) STUDY 3 - Safety Study: The safety assessment of the dengue vaccination will employ three approaches: a) active surveillance of patients treated or hospitalized with a

Eligibility

Age

15 Years to 59 Years

Inclusion criteria

Inclusion criteria: Botucatu residents (case-control and cohort) or Polo Cuesta residents (cohort study only) aged between 15 and 59 years; Individuals with suspected dengue infection to be investigated at Emergency Rooms or Primary Health Care Units; Performance of RT-PCR for dengue for residents of Botucatu and São Manuel (for cases from other Polo Cuesta municipalities, rapid NS1 antigen testing may also be considered).

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
A decrease in dengue cases is expected within a one-year period, verified through the investigation of suspected cases in the municipality where mass vaccination took place. To access this information, reports will be requested from the Municipal Epidemiological Surveillance department. These reports include government system data regarding dengue notifications and vaccination history (PNI), providing the necessary data for the cohort study. Consequently, the effectiveness rate of the Butantan vaccine will be calculated - considering effectiveness against both mild and severe dengue, stratified by viral serotype. In parallel, reports from neighboring cities (Polo Cuesta) will also be requested to serve as the control group for a test-negative case-control study. The cities of Botucatu and São Manuel (the most populous city in Polo Cuesta) will perform testing via RT-PCR; other municipalities in Polo Cuesta will conduct testing according to local protocols. Regarding safety analysis, the occurrence of adverse events in the municipality will be evaluated over the one-year period.	—

Measure

Time frame

A decrease in dengue cases is expected within a one-year period, verified through the investigation of suspected cases in the municipality where mass vaccination took place. To access this information, reports will be requested from the Municipal Epidemiological Surveillance department. These reports include government system data regarding dengue notifications and vaccination history (PNI), providing the necessary data for the cohort study. Consequently, the effectiveness rate of the Butantan vaccine will be calculated - considering effectiveness against both mild and severe dengue, stratified by viral serotype. In parallel, reports from neighboring cities (Polo Cuesta) will also be requested to serve as the control group for a test-negative case-control study. The cities of Botucatu and São Manuel (the most populous city in Polo Cuesta) will perform testing via RT-PCR; other municipalities in Polo Cuesta will conduct testing according to local protocols. Regarding safety analysis, the occurrence of adverse events in the municipality will be evaluated over the one-year period.

—

Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Brazil

Contacts

Public ContactCarlos Fortaleza

Faculdade de Medicina de Botucatu

carlos.fortaleza@unesp.br+55(14)3880-1284

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026