Typhoid FeverPhase 1NCT01123941
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
A Phase 1 study testing Typherix and NVGH Vi-CRM197 in people with Typhoid Fever, run by Novartis at 1 site in Belgium.
Trial summary
This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- Typherix and NVGH Vi-CRM197
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- May 2010to Nov 2010
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females of age ≥18 to ≤40 years.
- Individuals who, after the nature of the study has 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, hematological / hematochemical blood tests and urinalysis and clinical judgment of the investigator.
- If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration
Who cannot join
- 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, might interfere with the results of the study or 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.
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- Individuals with any serious chronic or progressive disease according to judgment of the investigator.
- 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 have previously received any vaccines against typhoid fever.
- Individuals who received any other vaccines within 4 weeks prior to enrollment 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 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 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center for the Evaluation of Vaccination (CEV)
Antwerp, Wilrijk (Antwerp), 2610
About this study
Official title: A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age.
This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.
- Conditions
- Typhoid Fever
- Being tested
- Typherix, NVGH Vi-CRM197
- Keywords
- Typhoid fever, Glycoconjugate vaccine, Carrier protein, 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.
TypherixBiological
1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide
NVGH Vi-CRM197Biological
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
| Study group | Role | What they receive |
|---|---|---|
| NVGH Vi-CRM197 conjugate vaccine | Experimental | Not described Receives: Biological: NVGH Vi-CRM197 |
| Vi-polysaccharide vaccine | Active comparator | Not described Receives: Biological: Typherix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Any Post Immunization Reactions
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.
Measured: During the 7-day period after vaccination
Number of Subjects Reporting Adverse Events
Measured: During the 28-day period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Measured: During the 6-month period after vaccination
Secondary outcomes (1)
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Measured: At 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionNov 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre VanDamme, Dr., Principal investigator, Center for the Evaluation of Vaccination (CEV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123941
- Sponsor's protocol ID
- H01_01TP
- Status last verified
- Dec 2013
- First submitted
- 13 May 2010
- Last updated
- 17 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
van Damme P, Kafeja F, Anemona A, Basile V, Hilbert AK, De Coster I, Rondini S, Micoli F, Qasim Khan RM, Marchetti E, Di Cioccio V, Saul A, Martin LB, Podda A. Safety, immunogenicity and dose ranging of a new Vi-CRM(1)(9)(7) conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults. PLoS One. 2011;6(9):e25398. doi: 10.1371/journal.pone.0025398. Epub 2011 Sep 30.
PubMed 21980445
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age.
- ClinicalTrials.gov ID
- NCT01123941
- Acronym / sponsor ID
- H01_01TP
- Conditions
- Typhoid Fever
- Keywords
- Typhoid fever, Glycoconjugate vaccine, Carrier protein, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Posted 13 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVGH Vi-CRM197 conjugate vaccine | Experimental | Biological: NVGH Vi-CRM197 |
| Vi-polysaccharide vaccine | Active comparator | Biological: Typherix |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females of age ≥18 to ≤40 years.
- Individuals who, after the nature of the study has 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, hematological / hematochemical blood tests and urinalysis and clinical judgment of the investigator.
- If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration
Key exclusion criteria (20 listed)
- 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, might interfere with the results of the study or 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.
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 |
|---|---|---|
| Typherix1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide | Biological | Vi-polysaccharide vaccine |
| NVGH Vi-CRM1971 dose of 0.5 mL containing 25 mcg of Vi-CRM | Biological | NVGH Vi-CRM197 conjugate vaccine |
Primary outcome
Number of Subjects Reporting Any Post Immunization Reactions
Time frame: During the 7-day period after vaccination
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.
Number of Subjects Reporting Adverse Events
Time frame: During the 28-day period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the 6-month period after vaccination
1 secondary outcome
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Time frame: At 28 days after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21980445van Damme P, Kafeja F, Anemona A, Basile V, Hilbert AK, De Coster I, Rondini S, Micoli F, Qasim Khan RM, Marchetti E, Di Cioccio V, Saul A, Martin LB, Podda A. Safety, immunogenicity and dose ranging of a new Vi-CRM(1)(9)(7) conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults. PLoS One. 2011;6(9):e25398. doi: 10.1371/journal.pone.0025398. Epub 2011 Sep 30.
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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 VanDamme, Dr. principal investigator
Center for the Evaluation of Vaccination (CEV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Typherix and 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 4 inclusion and 20 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 17 Jan 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 13 Jun 2012). 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?
Number of Subjects Reporting Any Post Immunization Reactions (time frame: During the 7-day period after vaccination). The study lists 3 primary outcomes in all. 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 NCT01123941, which also lists 1 linked publication.
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 17 Jan 2014.