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Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine

This study is currently recruiting participants.
Verified December 2016 by Butantan Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02406729
First Posted: April 2, 2015
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Butantan Institute
March 30, 2015
April 2, 2015
December 20, 2016
February 2016
May 2018   (Final data collection date for primary outcome measure)
  • Efficacy (incidence density of symptomatic dengue cases, virologically confirmed) [ Time Frame: at 52 weeks post vaccination, all cases after 28 days post-vaccination ]
    • The primary efficacy outcome is incidence density of symptomatic dengue cases, virologically confirmed, after 28 days post-vaccination. Virological confirmation might be done by viral isolation, RT-PCR and/or detection of NS1.
  • Safety (adverse reactions) [ Time Frame: in the first 21 days post-vaccination ]
    • The primary safety outcome is the frequency of local and systemic adverse reactions, solicited and non-solicited in the three age groups, within the first 21 days post-vaccination. Adverse reactions are defined as adverse events that have a reasonable causal relationship with vaccination.
  • Efficacy (ncidence density of symptomatic dengue cases, virologically confirmed) [ Time Frame: at 52 weeks post vaccination, all cases after 28 days post-vaccination ]
    • The primary efficacy outcome is incidence density of symptomatic dengue cases, virologically confirmed, after 28 days post-vaccination. Virological confirmation might be done by viral isolation, RT-PCR and/or detection of NS1.
  • Safety (adverse reactions) [ Time Frame: in the first 21 days post-vaccination ]
    • The primary safety outcome is the frequency of local and systemic adverse reactions, solicited and non-solicited in the three age groups, within the first 21 days post-vaccination. Adverse reactions are defined as adverse events that have a reasonable causal relationship with vaccination.
Complete list of historical versions of study NCT02406729 on ClinicalTrials.gov Archive Site
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Not Provided
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Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine
Phase III Trial to Evaluate Efficacy and Safety of a Dengue 1,2,3,4 (Attenuated) Vaccine

This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute.

The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission.

Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants.

For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start.

The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy.

All participants will be followed up for five years to verify dengue incidence, regardless severity.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Dengue
  • Biological: Dengue 1,2,3,4 (attenuated) vaccine
    Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous
    Other Names:
    • Butantan DV
    • TetraVax-DV-TV003
  • Other: Placebo
    Route:subcutaneous
  • Experimental: Dengue 1,2,3,4 (attenuated) vaccine
    Dengue 1,2,3,4 (attenuated) vaccine Single dose, SC
    Intervention: Biological: Dengue 1,2,3,4 (attenuated) vaccine
  • Placebo Comparator: Placebo
    Placebo Single dose, SC
    Intervention: Other: Placebo
Precioso AR, Palacios R, Thomé B, Mondini G, Braga P, Kalil J. Clinical evaluation strategies for a live attenuated tetravalent dengue vaccine. Vaccine. 2015 Dec 10;33(50):7121-5. doi: 10.1016/j.vaccine.2015.09.105. Epub 2015 Oct 14. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16944
November 2022
May 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age;
  2. Agree with periodic contacts, either/or by phone, electronic means, and home visits.
  3. Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form.

Exclusion Criteria:

  1. For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding;
  2. Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination;
  3. Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination;
  4. Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
  5. Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history;
  6. History of severe allergic reactions or anaphylaxis to the vaccine or to components of the vaccine in study;
  7. History of asplenia;
  8. Use of any investigational product within 28 days before or after receiving this study vaccination;
  9. Has participated in another clinical trial six months prior to inclusion in the study or planning to participate in another clinical trial within 2 years following inclusion;
  10. Use of immunosuppressant drugs such as: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use (except topical or nasal). For this protocol will be considered for exclusion use of corticosteroids 3 months prior to the inclusion in the study and 6 months prior to the inclusion for the other therapies mentioned, and planned use of any immunosuppressant therapy within 2 years following inclusion in the study. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥20 mg of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for children for over 7 days;
  11. Have received blood products in the past three months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the following 2 years after vaccination;
  12. Fever or suspected fever within 72 hours prior to vaccination or axillary temperature greater than 37,8°C on the day of vaccination (inclusion might be postponed until participant has completed 72 hours of no fever);
  13. Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 28 days after receiving the investigational product;
  14. Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.
Sexes Eligible for Study: All
24 Months to 59 Years   (Child, Adult)
Yes
Contact: Alexander R Precioso, MD, PhD +55(11)26279372 alexander.precioso@butantan.gov.br
Contact: Ricardo Palacios, MD, PhD +55(11)26279372 ricardo.palacios@butantan.gov.br
Brazil
 
 
NCT02406729
DEN-03-IB
U1111-1168-8679 ( Registry Identifier: UTN )
Yes
Not Provided
Not Provided
Butantan Institute
Butantan Institute
Not Provided
Study Director: Alexander R Precioso, MD, PhD Butantan Institute
Study Chair: Ricardo Palacios, MD, PHD Butantan Institute
Principal Investigator: Esper G Kallas, MD, PhD School of Medicine, University of São Paulo
Butantan Institute
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP