Typhoid FeverPhase 2NCT01193907

Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)

A Phase 2 study testing NVGH Vi-CRM197 12.5 mcg, NVGH Vi-CRM197 5.0 mcg and NVGH Vi-CRM197 1.25 mcg in people with Typhoid Fever, run by Novartis at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations of 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?: NVGH Vi-CRM197 12.5 mcg, NVGH Vi-CRM197 5.0 mcg and NVGH Vi-CRM197 1.25 mcg
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteBelgium
Study dates: Oct 2010to Nov 2010
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 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 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.
Individuals with negative urine screening tests for drug addition (Opiate, Cocaine, Amph/Metamphetamine, Cannabinoides )
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.

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 (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 have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines).
Individuals who received any other 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Center for the Evaluation of Vaccination (CEV)
Antwerp, Wilrijk (Antwerp), 2610

Other trials in Belgium

About this study

Official title: A Phase 2, Randomized, Observer-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of Three Formulations of the Novartis Vaccines Institute for Global Health (NVGH) Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age

Conditions: Typhoid Fever
Being tested: NVGH Vi-CRM197 12.5 mcg, NVGH Vi-CRM197 5.0 mcg, NVGH Vi-CRM197 1.25 mcg, Vi-polysaccharide vaccine
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-CRM197 12.5 mcgBiological
1 dose of 0.5 mL
NVGH Vi-CRM197 5.0 mcgBiological
1 dose of 0.5 mL
NVGH Vi-CRM197 1.25 mcgBiological
1 dose of 0.5 mL
Vi-polysaccharide vaccineBiological
1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide

Study groups in NCT01193907
Study group	Role	What they receive
NVGH Vi-CRM197 conjugate vaccine 12.5 mcg	Experimental	1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM Receives: Biological: NVGH Vi-CRM197 12.5 mcg
NVGH Vi-CRM197 conjugate vaccine 5 mcg	Experimental	1 dose of 0.5 mL containing 5 mcg of Vi-CRM Receives: Biological: NVGH Vi-CRM197 5.0 mcg
NVGH Vi-CRM197 conjugate vaccine 1.25 mcg	Experimental	1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM Receives: Biological: NVGH Vi-CRM197 1.25 mcg
Typherix	Active comparator	1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide Receives: Biological: Vi-polysaccharide vaccine

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
Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)
Measured: At 28 days after vaccination
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
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.

Oct 2010Nov 2010

First posted2 Sep 2010 (estimated)
Study startOct 2010
Primary completionNov 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01193907
Sponsor's protocol ID: H01_04TP
Other IDs: 2010-021874-12
Status last verified: Dec 2013
First submitted: 1 Sep 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Typhoid Fever trials

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 2, Randomized, Observer-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of Three Formulations of the Novartis Vaccines Institute for Global Health (NVGH) Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age
ClinicalTrials.gov ID: NCT01193907
Acronym / sponsor ID: H01_04TP
Conditions: Typhoid Fever
Keywords: Typhoid fever, Glycoconjugate vaccine, Vi polysaccharide, Immunogenicity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 2 Sep 2010 (estimated)
Results: Posted 3 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
NVGH Vi-CRM197 conjugate vaccine 12.5 mcg	Experimental	Biological: NVGH Vi-CRM197 12.5 mcg1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
NVGH Vi-CRM197 conjugate vaccine 5 mcg	Experimental	Biological: NVGH Vi-CRM197 5.0 mcg1 dose of 0.5 mL containing 5 mcg of Vi-CRM
NVGH Vi-CRM197 conjugate vaccine 1.25 mcg	Experimental	Biological: NVGH Vi-CRM197 1.25 mcg1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
Typherix	Active comparator	Biological: Vi-polysaccharide vaccine1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Males and females of age ≥18 to ≤40 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.
Individuals with negative urine screening tests for drug addition (Opiate, Cocaine, Amph/Metamphetamine, Cannabinoides )
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.

Key exclusion criteria (22 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
NVGH Vi-CRM197 12.5 mcg1 dose of 0.5 mL	Biological	NVGH Vi-CRM197 conjugate vaccine 12.5 mcg
NVGH Vi-CRM197 5.0 mcg1 dose of 0.5 mL	Biological	NVGH Vi-CRM197 conjugate vaccine 5 mcg
NVGH Vi-CRM197 1.25 mcg1 dose of 0.5 mL	Biological	NVGH Vi-CRM197 conjugate vaccine 1.25 mcg
Vi-polysaccharide vaccine1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide	Biological	Typherix

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
Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)
Time frame: At 28 days after vaccination
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
Time frame: At 28 days after vaccination

Results and safety

Results posted to the registry on 3 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NVGH Vi-CRM197 12.5 Mcg	22	21
NVGH Vi-CRM197 5.0 Mcg	22	22
NVGH Vi-CRM197 1.25 Mcg	22	22
Typherix	22	21

Primary outcome: Number of Subjects Reporting Any Post Immunization Reactions

Time frame: During the 7-day period after vaccination. Number. Unit: participants

Measure	NVGH Vi-CRM197 12.5 Mcg n = 21	NVGH Vi-CRM197 5.0 Mcg n = 22	NVGH Vi-CRM197 1.25 Mcg n = 22	Typherix n = 22
Value	18	19	22	16

Primary outcome: Number of Subjects Reporting Adverse Events

Time frame: During the 28-day period after vaccination. Number. Unit: participants

Measure	NVGH Vi-CRM197 12.5 Mcg n = 21	NVGH Vi-CRM197 5.0 Mcg n = 22	NVGH Vi-CRM197 1.25 Mcg n = 22	Typherix n = 22
Value	11	16	18	15

Primary outcome: Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)

Time frame: At 28 days after vaccination. Mean (95% Confidence Interval). Unit: GMC

Measure	NVGH Vi-CRM197 12.5 Mcg n = 21	NVGH Vi-CRM197 5.0 Mcg n = 21	NVGH Vi-CRM197 1.25 Mcg n = 19	Typherix n = 20
Value	192 (129 to 286)	111 (75 to 165)	63 (41 to 95)	37 (24 to 55)

Primary outcome: Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer

Time frame: At 28 days after vaccination. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	NVGH Vi-CRM197 12.5 Mcg n = 21	NVGH Vi-CRM197 5.0 Mcg n = 21	NVGH Vi-CRM197 1.25 Mcg n = 19	Typherix n = 20
Value	100 (84 to 100)	100 (84 to 100)	95 (74 to 100)	95 (75 to 100)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NVGH Vi-CRM197 12.5 Mcg	0 of 21 (0%)	19 of 21 (90.5%)	Not reported
NVGH Vi-CRM197 5.0 Mcg	0 of 22 (0%)	19 of 22 (86.4%)	Not reported
NVGH Vi-CRM197 1.25 Mcg	0 of 22 (0%)	22 of 22 (100%)	Not reported
Typherix	0 of 22 (0%)	19 of 22 (86.4%)	Not reported

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.

The record lists no contact. Use the official record to reach the sponsor.

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 12.5 mcg, NVGH Vi-CRM197 5.0 mcg and NVGH Vi-CRM197 1.25 mcg 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 5 inclusion and 22 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 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 3 Apr 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 4 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 NCT01193907, 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.