DengueRIMVADENCT07158190
Evaluation of T-cell Responses After Vaccination With the Attenuated Tetravalent Dengue Vaccine (Takeda).
An observational study of Dengue, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Dengue is one of the most epidemiologically and clinically relevant arboviral diseases, affecting half of the global population. This disease is caused by one of the four serotypes of the dengue virus (DENV1-4), belonging to the flavivirus family transmitted to humans by Aedes aegypti and Aedes albopictus mosquitoes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Vaccine
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who have never contracted the dengue infection and individuals who have previously been confirmed dengue seropositive through laboratory analysis.
Who may be able to join
- Women/Men aged between 18 and 65 years old; generally in good health, confirmed through a medical history questionnaire and basic laboratory tests;
- availability for the duration of the study, approximately 26 weeks after vaccination;
- willingness to sign an informed consent form, acknowledging understanding of the objectives, procedures, and risks associated with the stud
Who cannot join
- current pregnancy or breastfeeding;
- recent hospitalization or serious illness in the past four weeks;
- evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on medical history, physical examination, and/or laboratory studies;
- behavioral, cognitive, or psychiatric disorders that, in the opinion of the investigator, impact the participant's ability to understand and comply with the study protocol;
- laboratory values of grade 1 or higher for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine as defined in the protocol;
- any other condition that, in the opinion of the investigator, could compromise participant safety or rights in the study or make the participant unable to follow the protocol;
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- significant alcohol or drug abuse in the past 12 months resulting in medical, occupational, or family problems, as indicated by the participant's history;
- history of severe allergic reaction or anaphylaxis;
- severe asthma (emergency room visit or hospitalization in the past 6 months);
- current viral infection;
- use of anticoagulant medications;
- use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days before or after vaccination. Immunosuppressive dose of corticosteroids is defined as equal to or greater than 10 mg of prednisone equivalent per day for equal to or greater than 14 days;
- receipt of a live vaccine within 28 days or an inactivated vaccine within 14 days prior to vaccination, or expected receipt of any vaccine within 42 days after vaccination; asplenia;
- receipt of blood products in the past 6 months, including transfusions or immunoglobulins, or expected receipt of any blood product or immunoglobulin within 42 days after vaccination.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universtiario Agostino Gemelli IRCCS
Rome, Roma, 00168
About this study
Dengue is one of the most epidemiologically and clinically relevant arboviral diseases, affecting half of the global population. This disease is caused by one of the four serotypes of the dengue virus (DENV1-4), belonging to the flavivirus family transmitted to humans by Aedes aegypti and Aedes albopictus mosquitoes. Dengue is not endemic in Europe, and recorded cases are almost exclusively imported by individuals who have recently visited endemic areas. In Italy, several imported cases are recorded every year, although in the past summer season of 2023, numerous autochthonous cases of dengue were observed, with a particular incidence in Rome and Lazio. In 75-80% of cases the first infection is asymptomatic or paucisymptomatic, while in 20-25% of cases flu-like symptoms may appear, in more severe cases, dengue hemorrhagic fever may occur. Individuals who are infected for the first time are protected for life from that particular serotype that caused the infection. However, Individuals who are infected for the second time with a different serotype are at greater risk of severe dengue.To reduce the risk of dengue epidemics, the most effective method is a systematic and continuous mosquito control. Although the use of an effective vaccine remains a primary prevention measure that should be integrated into the healthcare system. The recent vaccine developed, TAK-003, is an innovative live attenuated vaccine based on serotype 2 (DENV-2), which uses recombinant technology to ensure immunization against all four virus serotypes. However, it showed the highest efficacy against DENV-2, both in seropositive and seronegative people.
To date, there is partial knowledge of the dynamics between viral and host factors that influence the development of disease caused by DENV. In this infections it has been observed that T lymphocytes play a crucial role in dealing with viral pathogens with both harmful and beneficial effects. A debate still persists as whether memory T lymphocytes play solely a protective role in secondary DENV infections or may instead have the potential to contribute to immunopathological mechanisms leading to severe forms of dengue.
Our study aims are to investigate the responses of T lymphocytes against DENV, identifying reliable and meaningful markers of protection. This will be achieved by analyzing the response of T lymphocytes to DENV1-4 serotype epitopes in subjects who will be vaccinated with the attenuated tetravalent dengue TAK003.
Read the detailed description
Inclusion criteria:
Women/Men aged between 18 and 65 years old; generally in good health, confirmed through a medical history questionnaire and basic laboratory tests; availability for the duration of the study, approximately 26 weeks after vaccination; willingness to sign an informed consent form, acknowledging understanding of the objectives, procedures, and risks associated with the study.
Exclusion criteria:
current pregnancy or breastfeeding; recent hospitalization or serious illness in the past four weeks; evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on medical history, physical examination, and/or laboratory studies; behavioral, cognitive, or psychiatric disorders that, in the opinion of the investigator, impact the participant's ability to understand and comply with the study protocol; laboratory values of grade 1 or higher for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine as defined in the protocol; any other condition that, in the opinion of the investigator, could compromise participant safety or rights in the study or make the participant unable to follow the protocol; significant alcohol or drug abuse in the past 12 months resulting in medical, occupational, or family problems, as indicated by the participant's history; history of severe allergic reaction or anaphylaxis; severe asthma (emergency room visit or hospitalization in the past 6 months); current viral infection; use of anticoagulant medications; use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days before or after vaccination. Immunosuppressive dose of corticosteroids is defined as equal to or greater than 10 mg of prednisone equivalent per day for equal to or greater than 14 days; receipt of a live vaccine within 28 days or an inactivated vaccine within 14 days prior to vaccination, or expected receipt of any vaccine within 42 days after vaccination; asplenia; receipt of blood products in the past 6 months, including transfusions or immunoglobulins, or expected receipt of any blood product or immunoglobulin within 42 days after vaccination.
- Conditions
- Dengue
- Being tested
- Vaccine
- Keywords
- Vaccination, T cell response
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccineBiological
Vaccine TAK003 administration
| Study group | Role | What they receive |
|---|---|---|
| 30 volunteers | Individuals who have never contracted the dengue infection and individuals who have previously been confirmed dengue seropositive through laboratory analysis. Receives: Biological: Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
analysis of antibody titres and T cell
Humoral and cellular immunity to the tetravalent Dengue vaccine (Takeda), assessed through analysis of antibody titers and analysis of T cell responses to epitopes of viral antigens C, E, NS2, NS3, NS4, NS5, prM.
Measured: 12 months
Secondary outcomes (3)
T cell against DENV1-4
correlation between T cell response and antibody tirtrest against DENV1-4
Measured: 12months
comparison antibody and cell response
comparison between cell and antibody response, among sieropositive and sieronegative subjects.
Measured: 12 months
phenotypical charaterization
phenotypical charaterization of Dengue specific T cell induced by vaccination
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start30 Jun 2024
- Primary completion30 Jun 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Torti, Prof, Principal investigator, Fondazione Policlinico Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158190
- Sponsor's protocol ID
- 6832
- Acronym
- RIMVADE
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
PubMed 23563266Tricou V, Yu D, Reynales H, Biswal S, Saez-Llorens X, Sirivichayakul C, Lopez P, Borja-Tabora C, Bravo L, Kosalaraksa P, Vargas LM, Alera MT, Rivera L, Watanaveeradej V, Dietze R, Fernando L, Wickramasinghe VP, Moreira ED Jr, Fernando AD, Gunasekera D, Luz K, Oliveira AL, Tuboi S, Escudero I, Hutagalung Y, Lloyd E, Rauscher M, Zent O, Folschweiller N, LeFevre I, Espinoza F, Wallace D. Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4.5-year results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2024 Feb;12(2):e257-e270. doi: 10.1016/S2214-109X(23)00522-3.
PubMed 38245116Tian Y, Sette A, Weiskopf D. Cytotoxic CD4 T Cells: Differentiation, Function, and Application to Dengue Virus Infection. Front Immunol. 2016 Dec 7;7:531. doi: 10.3389/fimmu.2016.00531. eCollection 2016.
PubMed 28003809
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of T-cell Responses After Vaccination With the Attenuated Tetravalent Dengue Vaccine (Takeda).
- ClinicalTrials.gov ID
- NCT07158190
- Acronym / sponsor ID
- RIMVADE / 6832
- Conditions
- Dengue
- Keywords
- Vaccination, T cell response
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dengue is one of the most epidemiologically and clinically relevant arboviral diseases, affecting half of the global population. This disease is caused by one of the four serotypes of the dengue virus (DENV1-4), belonging to the flavivirus family transmitted to humans by Aedes aegypti and Aedes albopictus mosquitoes. Dengue is not endemic in Europe, and recorded cases are almost exclusively imported by individuals who have recently visited endemic areas. In Italy, several imported cases are recorded every year, although in the past summer season of 2023, numerous autochthonous cases of dengue were observed, with a particular incidence in Rome and Lazio. In 75-80% of cases the first infection is asymptomatic or paucisymptomatic, while in 20-25% of cases flu-like symptoms may appear, in more severe cases, dengue hemorrhagic fever may occur. Individuals who are infected for the first time are protected for life from that particular serotype that caused the infection. However, Individuals who are infected for the second time with a different serotype are at greater risk of severe dengue.To reduce the risk of dengue epidemics, the most effective method is a systematic and continuous mosquito control. Although the use of an effective vaccine remains a primary prevention measure that should be integrated into the healthcare system. The recent vaccine developed, TAK-003, is an innovative live attenuated vaccine based on serotype 2 (DENV-2), which uses recombinant technology to ensure immunization against all four virus serotypes. However, it showed the highest efficacy against DENV-2, both in seropositive and seronegative people.
To date, there is partial knowledge of the dynamics between viral and host factors that influence the development of disease caused by DENV. In this infections it has been observed that T lymphocytes play a crucial role in dealing with viral pathogens with both harmful and beneficial effects. A debate still persists as whether memory T lymphocytes play solely a protective role in secondary DENV infections or may instead have the potential to contribute to immunopathological mechanisms leading to severe forms of dengue.
Our study aims are to investigate the responses of T lymphocytes against DENV, identifying reliable and meaningful markers of protection. This will be achieved by analyzing the response of T lymphocytes to DENV1-4 serotype epitopes in subjects who will be vaccinated with the attenuated tetravalent dengue TAK003.
Detailed description
Inclusion criteria:
Women/Men aged between 18 and 65 years old; generally in good health, confirmed through a medical history questionnaire and basic laboratory tests; availability for the duration of the study, approximately 26 weeks after vaccination; willingness to sign an informed consent form, acknowledging understanding of the objectives, procedures, and risks associated with the study.
Exclusion criteria:
current pregnancy or breastfeeding; recent hospitalization or serious illness in the past four weeks; evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on medical history, physical examination, and/or laboratory studies; behavioral, cognitive, or psychiatric disorders that, in the opinion of the investigator, impact the participant's ability to understand and comply with the study protocol; laboratory values of grade 1 or higher for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine as defined in the protocol; any other condition that, in the opinion of the investigator, could compromise participant safety or rights in the study or make the participant unable to follow the protocol; significant alcohol or drug abuse in the past 12 months resulting in medical, occupational, or family problems, as indicated by the participant's history; history of severe allergic reaction or anaphylaxis; severe asthma (emergency room visit or hospitalization in the past 6 months); current viral infection; use of anticoagulant medications; use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days before or after vaccination. Immunosuppressive dose of corticosteroids is defined as equal to or greater than 10 mg of prednisone equivalent per day for equal to or greater than 14 days; receipt of a live vaccine within 28 days or an inactivated vaccine within 14 days prior to vaccination, or expected receipt of any vaccine within 42 days after vaccination; asplenia; receipt of blood products in the past 6 months, including transfusions or immunoglobulins, or expected receipt of any blood product or immunoglobulin within 42 days after vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 volunteers | – | Biological: VaccineIndividuals who have never contracted the dengue infection and individuals who have previously been confirmed dengue seropositive through laboratory analysis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have never contracted the dengue infection and individuals who have previously been confirmed dengue seropositive through laboratory analysis.
Key inclusion criteria (3 listed)
- Women/Men aged between 18 and 65 years old; generally in good health, confirmed through a medical history questionnaire and basic laboratory tests;
- availability for the duration of the study, approximately 26 weeks after vaccination;
- willingness to sign an informed consent form, acknowledging understanding of the objectives, procedures, and risks associated with the stud
Key exclusion criteria (14 listed)
- current pregnancy or breastfeeding;
- recent hospitalization or serious illness in the past four weeks;
- evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on medical history, physical examination, and/or laboratory studies;
- behavioral, cognitive, or psychiatric disorders that, in the opinion of the investigator, impact the participant's ability to understand and comply with the study protocol;
- laboratory values of grade 1 or higher for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine as defined in the protocol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaccineVaccine TAK003 administration | Biological | 30 volunteers |
Primary outcome
analysis of antibody titres and T cell
Time frame: 12 months
Humoral and cellular immunity to the tetravalent Dengue vaccine (Takeda), assessed through analysis of antibody titers and analysis of T cell responses to epitopes of viral antigens C, E, NS2, NS3, NS4, NS5, prM.
3 secondary outcomes
T cell against DENV1-4
Time frame: 12months
comparison antibody and cell response
Time frame: 12 months
phenotypical charaterization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 23563266Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
- Results publication: PubMed 38245116Tricou V, Yu D, Reynales H, Biswal S, Saez-Llorens X, Sirivichayakul C, Lopez P, Borja-Tabora C, Bravo L, Kosalaraksa P, Vargas LM, Alera MT, Rivera L, Watanaveeradej V, Dietze R, Fernando L, Wickramasinghe VP, Moreira ED Jr, Fernando AD, Gunasekera D, Luz K, Oliveira AL, Tuboi S, Escudero I, Hutagalung Y, Lloyd E, Rauscher M, Zent O, Folschweiller N, LeFevre I, Espinoza F, Wallace D. Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4.5-year results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2024 Feb;12(2):e257-e270. doi: 10.1016/S2214-109X(23)00522-3.
- Results publication: PubMed 28003809Tian Y, Sette A, Weiskopf D. Cytotoxic CD4 T Cells: Differentiation, Function, and Application to Dengue Virus Infection. Front Immunol. 2016 Dec 7;7:531. doi: 10.3389/fimmu.2016.00531. eCollection 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Torti, Prof principal investigator
Fondazione Policlinico Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of antibody titres and T cell (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07158190, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.