Typhoid FeverPhase 2NCT01438996
Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults
A Phase 2 study testing NVGH Vi-CRM197 in people with Typhoid Fever, run by Novartis at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi antibody response following secondary vaccination with the Novartis Vaccines Institute for Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either the NVGH Vi-CRM197 or Vi-polysaccharide… Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- NVGH Vi-CRM197
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2011to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Subjects:
- Males and females of age ≥18 to ≤42 years.
- Individuals, who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- If women, use of birth control one month before study start, a negative pregnancy test and willingness to use birth control measures for the entire study duration.
- H0104TP subjects only:
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- Individuals who previously participated in the H01_04TP study and were vaccinated with either NVGH Vi-CRM197 (5μg) or with the licensed Vi-PS.
- Individuals who have received no Vi vaccination subsequent to the one received in the H01_04TP study.
- All subjects:
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
- Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
- Individuals with history of any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
- Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
- Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- Individuals who have any malignancy or lymphoproliferative disorder.
- Individuals with history of allergy to vaccine components.
- Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
- Individuals who received any vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine
- Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
- Individuals who are part of study personnel or close family members to the personnel conducting this study.
- Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study immunization.
- BMI > 35 kg/m2.
- Individuals with history of substance or alcohol abuse within the past 2 years.
- Women who are pregnant or breast-feeding or of childbearing age who have not used any birth control measure one month prior to study start or do not plan to use acceptable birth control measures, for the duration of the study.
- Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
- Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
- Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
- Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.
- Naïve subjects only:
- Individuals who have previously received any vaccine against typhoid fever (either oral live attenuated or injectable vaccines)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre for the Evaluation of Vaccination (CEV)
Antwerp, Wilrijk, 2610
About this study
Official title: A Phase 2, Open-label, Single-center, Extension Study to Evaluate the Booster Response Induced by Vi-CRM197 After Priming With Either Vi-CRM197 or Typherix Administered in Adult Subjects in H01_04TP Study (NCT01193907)
The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi antibody response following secondary vaccination with the Novartis Vaccines Institute for Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and the immunogenicity and the kinetics of the anti-Vi antibody response following primary vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.
- Conditions
- Typhoid Fever
- Being tested
- NVGH Vi-CRM197
- Keywords
- Typhoid fever, Glycoconjugate vaccine, Vi polysaccharide, Immunogenicity
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVGH Vi-CRM197Biological
Vi-CRM197 glycoconjugated vaccine
| Study group | Role | What they receive |
|---|---|---|
| NVGH Vi-CRM/NVGH Vi-CRM | Experimental | One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study Receives: Biological: NVGH Vi-CRM197 |
| Vi-PS/NVGH Vi-CRM | Experimental | One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study Receives: Biological: NVGH Vi-CRM197 |
| NVGH Vi-CRM | Experimental | One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults Receives: Biological: NVGH Vi-CRM197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Vi ELISA Geometric Mean Concentration (GMC)
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)
Measured: At 3 days after vaccination
Anti-Vi ELISA GMC
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA
Measured: At 7 days after vaccination
Anti-Vi ELISA GMC
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA
Measured: At 28 days after vaccination
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Measured: At 3 days after vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Measured: At 7 days after vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Measured: At 28 days after vaccination as compared to baseline
Secondary outcomes (3)
Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia, fatigue and fever.
Measured: During the 7-day period after vaccination
Number of Subjects Reporting AE
AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)
Measured: During the 28-day period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Measured: During the 28-day period after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Typhoid FeverStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Van Damme, MD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438996
- Sponsor's protocol ID
- H01_04E1TP
- Status last verified
- Feb 2014
- First submitted
- 19 Sep 2011
- Last updated
- 24 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Single-center, Extension Study to Evaluate the Booster Response Induced by Vi-CRM197 After Priming With Either Vi-CRM197 or Typherix Administered in Adult Subjects in H01_04TP Study (NCT01193907)
- ClinicalTrials.gov ID
- NCT01438996
- Acronym / sponsor ID
- H01_04E1TP
- Conditions
- Typhoid Fever
- Keywords
- Typhoid fever, Glycoconjugate vaccine, Vi polysaccharide, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Posted 24 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi antibody response following secondary vaccination with the Novartis Vaccines Institute for Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and the immunogenicity and the kinetics of the anti-Vi antibody response following primary vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NVGH Vi-CRM/NVGH Vi-CRM | Experimental | Biological: NVGH Vi-CRM197One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study |
| Vi-PS/NVGH Vi-CRM | Experimental | Biological: NVGH Vi-CRM197One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study |
| NVGH Vi-CRM | Experimental | Biological: NVGH Vi-CRM197One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (32 listed)
- Males and females of age ≥18 to ≤42 years.
- Individuals, who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- If women, use of birth control one month before study start, a negative pregnancy test and willingness to use birth control measures for the entire study duration.
- Individuals who previously participated in the H01_04TP study and were vaccinated with either NVGH Vi-CRM197 (5μg) or with the licensed Vi-PS.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NVGH Vi-CRM197Vi-CRM197 glycoconjugated vaccine | Biological | NVGH Vi-CRM, NVGH Vi-CRM/NVGH Vi-CRM, Vi-PS/NVGH Vi-CRM |
Primary outcome
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Time frame: At 3 days after vaccination
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)
Anti-Vi ELISA GMC
Time frame: At 7 days after vaccination
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA
Anti-Vi ELISA GMC
Time frame: At 28 days after vaccination
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Time frame: At 3 days after vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Time frame: At 7 days after vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Time frame: At 28 days after vaccination as compared to baseline
3 secondary outcomes
Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction
Time frame: During the 7-day period after vaccination
Number of Subjects Reporting AE
Time frame: During the 28-day period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the 28-day period after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pierre Van Damme, MD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVGH Vi-CRM197 in people with Typhoid Fever, run by Novartis at 1 site in Belgium.
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 32 inclusion and 0 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: finished, as of the sponsor's last update on 24 Mar 2014. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anti-Vi ELISA Geometric Mean Concentration (GMC) (time frame: At 3 days after vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2014.