Typhoid FeverPhase 1NCT00326443
CVD 909 Vi Prime Boost Study
A Phase 1 study testing CVD 909 and Vi Polysaccharide in people with Typhoid Fever, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this research study is to see if giving a typhoid vaccine by mouth (an experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see whether CVD 909 is safe. 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?
- CVD 909 and Vi Polysaccharide
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age 18 - 40 years, inclusive.
- Good general health as determined by a screening evaluation within 30 days before administration of CVD 909 or placebo.
- Expressed interest and availability to fulfill the study requirements.
- Informed, written consent.
- Agrees not to participate in another investigational vaccine or drug trial for the first 84 days of this study.
- Agrees not to become pregnant from the time of study enrollment until at least 56 days after the administration of CVD 909 or placebo; if a woman is sexually active and capable of conception (i.e., no history of hysterectomy or tubal ligation), she must agree to use hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male.
Who cannot join
- History of any of the following medical illnesses:
- Gall bladder disease or gall stones without cholecystectomy
- Diabetes
- Cancer
- Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
- Unconsciousness
Show all 51Show fewer
- Seizures (other than febrile seizures as a child less than 5 years old)
- Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
- Any current illness requiring daily medication other than vitamins, birth control, or stable regimen of anti-histamine medication for hay fever or anti-depressant
- History of the following types of abdominal surgery:
- Any major gastrointestinal surgery (e.g., intestinal resection or splenectomy)
- A laparotomy for any reason (e.g., hysterectomy, Caesarean section, appendectomy, or herniorrhaphy) within the last 3 years
- Laparoscopic abdominal surgery within the past year
- A large abdominal scar of unclear origin
- Evidence of gastrointestinal disease, as indicated by any of the following:
- Usual bowel habit of more than 3 bowel movements each day
- Recurrent diarrhea (greater than 5 episodes during the past 6 months, each lasting at least 3 days, with at least one week between episodes)
- Lactose intolerance
- Frequent indigestion or heartburn that requires daily antacids or other medical therapy
- Diagnosed by a doctor as having irritable bowel disease, Crohn's disease, ulcerative colitis, celiac disease, stomach or intestinal ulcers in the past 10 years
- Blood in the stool during the past year (other than occasional small amount from straining)
- Any clinically significant abnormality detected on physical examination, including:
- Murmur (other than a functional murmur)
- Focal neurological deficit suggesting a pathologic process
- Hepatosplenomegaly
- Lymphadenopathy
- Jaundice
- Hypertension (BP greater than 150/90 mm Hg on two separate days) or hypotension (BP less than 85/55 mm Hg)
- Any lab abnormality, as listed below:
- WBC outside the normal range
- Hemoglobin outside the normal range
- Platelet count outside the normal range
- Creatinine outside the normal range
- Fasting glucose greater than 115 mg/dl (if screening greater than 115 mg/dl)
- AST or ALT outside the normal range (may be repeated once if outside this limit)
- Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen
- Stool culture positive for Salmonella spp, Shigella spp, Campylobacter jejuni, V. cholerae, or pathogenic protozoa
- For women, positive serum pregnancy test within 7 days and urine pregnancy test within 24 hours of administering CVD 909 and within 24 hours of administering Vi vaccine
- Nursing mother
- Oral temperature greater than 37.8ºC or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis on the day of administration of CVD 909 or placebo
- Immunization against typhoid fever or history of typhoid fever
- Allergy to quinolones (including ciprofloxacin) or sulfa drugs (Including trimethoprim/sulfamethoxazole)
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- Failure to pass written examination about study purpose, background, and procedures (70% correct answers required to pass)
- Receipt of an investigational vaccine or drug within 28 days before administration of CVD 909
- Commercial food-handlers
- Health care workers who are engaged in patient care during the study
- Day care providers
- Subject with a household contact who is less than 2 years of age, who is immunocompromised or pregnant, or who works as a commercial food-handler
- Use of antibiotics within 7 days of CVD 909 or placebo vaccination
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Phase I Randomized, Double-Blind, Heterologous Prime-Boost Study of the Safety and Immunogenicity of Vi Polysaccharide Typhoid Vaccine After Priming by Live Attenuated Oral Vi+ Salmonella Typhi Strain CVD 909
The purpose of this research study is to see if giving a typhoid vaccine by mouth (an experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see whether CVD 909 is safe. Typhim Vi has been shown to be safe and effective in preventing typhoid fever in older children and adults, but it does not work in children under age 2. Scientists at the University of Maryland think that young children could respond to Typhim Vi if they were given a dose of the other typhoid vaccine by mouth before they are given the Typhim Vi shot. Twenty-eight healthy adult volunteers, ages 18-40 years, will take part in this study. Study participation will last for up to 63 weeks, but most of the study visits will be in the first 6 weeks. Blood samples will be collected approximately 13 times. Four stool samples will be collected. Some volunteers may be followed for an additional 4 years.
Read the detailed description
This is a phase I, randomized, double-blind, heterologous prime-boost study of the safety and immunogenicity of Vi polysaccharide typhoid vaccine after priming by live, attenuated oral Vi+ Salmonella Typhi strain CVD 909. The primary study objective is to determine the phase 1 safety of the prime-boost regimen of priming with CVD 909, a live attenuated Vi+ S. Typhi strain, followed by boosting with licensed parenteral Vi polysaccharide vaccine in healthy adult volunteers. The secondary objective is to compare the immunogenicity of licensed parenteral Vi polysaccharide vaccine in volunteers primed with a single oral dose of CVD 909 and in volunteers who are not primed with the oral vaccine. The outcome measures of interest are the seroconversion rate and titer of serum IgG anti-Vi antibodies, the timing of development and longevity of serum anti-Vi antibodies, the subclasses and avidity of antibodies developed, and the memory B and T cell responses elicited. The following immunologic outcome measures will be sought: rate and timing of seroconversion in each study arm after receiving Vi polysaccharide and analysis of immunoglobulin subclasses and avidity. This will assess the presence of priming and the rapidity of the anamnestic response. A successful priming would accelerate the response to the boost (Day 7 after Vi vaccine), and this response is expected to be more balanced, inducing both Th1/Th2-type immunity evidenced by the induction of both IgG1 and IgG2; geometric mean titer (GMT) of serum IgG anti-Vi antibodies on Days 7, 14, 21, and 35 post-Vi (Days 28, 35, 42, and 84 of the study). This will assess magnitude of response (another measure of priming); GMT of serum IgG Vi antibody in each study arm at multiple later time points up to 1 year after receiving parenteral Vi (week 55 of the study). This will assess the quality and duration of the antibodies; and peripheral blood mononuclear cells will be collected to measure cytokine production and cytotoxic T lymphocyte (CTL) activity, as well as the induction and maintenance of B and T cell memory responses and homing potential of antibody secreting cells (ASC) and T cells depending on cell numbers. Twenty-eight healthy adult volunteers, 18-40 years of age and from the Baltimore community, will be recruited to participate in this study, which will be conducted at the Center for Vaccine Development (CVD), University of Maryland School of Medicine. The volunteers will be randomized to receive either 5x10^9 colony forming units of CVD 909 with buffer or buffer placebo alone. Three weeks later, all volunteers will receive 25 micrograms (0.5 ml) of licensed purified Vi polysaccharide vaccine by the intramuscular route. Blood for serum and antibody secreting cell responses to Vi, S. Typhi LPS, and O antigen will be drawn before and after the Vi boost. The patient participation duration is up to 63 weeks, with the option for prolonged immunologic follow-up for 4 additional years.
- Conditions
- Typhoid Fever
- Being tested
- CVD 909, Placebo, Vi Polysaccharide
- Keywords
- Salmonella, vaccine, typhoid fever, S. Typhi
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVD 909Biological
5 X 10^9 CFU of oral S. Typhi vaccine strain CVD 909 with buffer administered on Day 0.
PlaceboDrug
Buffer placebo administered on Day 0.
Vi PolysaccharideBiological
25 micrograms (0.5 ml) of licensed purified Vi polysaccharide vaccine on Day 21.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 14 subjects Oral CVD 909 with buffer on Day 0. Parental Vi polysaccharide vaccine on Day 21. Receives: Biological: CVD 909; Biological: Vi Polysaccharide |
| 2 | Placebo comparator | 14 subjects oral buffer placebo. Parental Vi polysaccharide vaccine on Day 21. Receives: Drug: Placebo; Biological: Vi Polysaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: determined by symptom diaries, interim medical histories obtained by interview, by blood and stool cultures, and by clinical laboratory tests.
Measured: During the 1st 14 days after ingestion of CVD 909 vaccine or placebo, during the 3 days after receiving parenteral Typhim Vi vaccine at Day 24, and interim medical history for safety at Day 42.
Secondary outcomes (4)
Immunogenicity: assessed by specific antibody secreting cell assays.
Measured: Days 0 and 10 after oral administration of CVD 909 and Days 0 and 7 after administration of parenteral Vi.
The timing of development and longevity of serum anti-Vi antibodies.
Measured: Days 0 and 10 after oral administration of CVD 909 and Days 0 and 7 after administration of parenteral Vi.
The subclasses and avidity of antibodies developed.
Measured: Days 0 and 10 after oral administration of CVD 909 and Days 0 and 7 after administration of parenteral Vi.
Seroconversion rate and titer of serum IgG anti-Vi antibodies.
Measured: Days 0, 10, 14+/-2, 21+/-2, 28+/-2, 35+/-2, 42+/-2, and 84+/-7 and at 29+/-2 weeks and 55+/- 4 weeks, and every 6 months for 4 years for volunteers who remain seropositive at week 55 and agree to continue participation in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Typhoid FeverStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326443
- Sponsor's protocol ID
- 05-0009
- Other IDs
- Typhoid CVD 36000
- Status last verified
- Feb 2010
- First submitted
- 12 May 2006
- Last updated
- 9 May 2014
- Results posted
- No
Publications
Wahid R, Zafar SJ, McArthur MA, Pasetti MF, Levine MM, Sztein MB. Live oral Salmonella enterica serovar Typhi vaccines Ty21a and CVD 909 induce opsonophagocytic functional antibodies in humans that cross-react with S. Paratyphi A and S. Paratyphi B. Clin Vaccine Immunol. 2014 Mar;21(3):427-34. doi: 10.1128/CVI.00786-13. Epub 2014 Jan 15.
PubMed 24429069
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized, Double-Blind, Heterologous Prime-Boost Study of the Safety and Immunogenicity of Vi Polysaccharide Typhoid Vaccine After Priming by Live Attenuated Oral Vi+ Salmonella Typhi Strain CVD 909
- ClinicalTrials.gov ID
- NCT00326443
- Acronym / sponsor ID
- 05-0009
- Conditions
- Typhoid Fever
- Keywords
- Salmonella, vaccine, typhoid fever, S. Typhi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 May 2006 (estimated)
- 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.
The purpose of this research study is to see if giving a typhoid vaccine by mouth (an experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see whether CVD 909 is safe. Typhim Vi has been shown to be safe and effective in preventing typhoid fever in older children and adults, but it does not work in children under age 2. Scientists at the University of Maryland think that young children could respond to Typhim Vi if they were given a dose of the other typhoid vaccine by mouth before they are given the Typhim Vi shot. Twenty-eight healthy adult volunteers, ages 18-40 years, will take part in this study. Study participation will last for up to 63 weeks, but most of the study visits will be in the first 6 weeks. Blood samples will be collected approximately 13 times. Four stool samples will be collected. Some volunteers may be followed for an additional 4 years.
Detailed description
This is a phase I, randomized, double-blind, heterologous prime-boost study of the safety and immunogenicity of Vi polysaccharide typhoid vaccine after priming by live, attenuated oral Vi+ Salmonella Typhi strain CVD 909. The primary study objective is to determine the phase 1 safety of the prime-boost regimen of priming with CVD 909, a live attenuated Vi+ S. Typhi strain, followed by boosting with licensed parenteral Vi polysaccharide vaccine in healthy adult volunteers. The secondary objective is to compare the immunogenicity of licensed parenteral Vi polysaccharide vaccine in volunteers primed with a single oral dose of CVD 909 and in volunteers who are not primed with the oral vaccine. The outcome measures of interest are the seroconversion rate and titer of serum IgG anti-Vi antibodies, the timing of development and longevity of serum anti-Vi antibodies, the subclasses and avidity of antibodies developed, and the memory B and T cell responses elicited. The following immunologic outcome measures will be sought: rate and timing of seroconversion in each study arm after receiving Vi polysaccharide and analysis of immunoglobulin subclasses and avidity. This will assess the presence of priming and the rapidity of the anamnestic response. A successful priming would accelerate the response to the boost (Day 7 after Vi vaccine), and this response is expected to be more balanced, inducing both Th1/Th2-type immunity evidenced by the induction of both IgG1 and IgG2; geometric mean titer (GMT) of serum IgG anti-Vi antibodies on Days 7, 14, 21, and 35 post-Vi (Days 28, 35, 42, and 84 of the study). This will assess magnitude of response (another measure of priming); GMT of serum IgG Vi antibody in each study arm at multiple later time points up to 1 year after receiving parenteral Vi (week 55 of the study). This will assess the quality and duration of the antibodies; and peripheral blood mononuclear cells will be collected to measure cytokine production and cytotoxic T lymphocyte (CTL) activity, as well as the induction and maintenance of B and T cell memory responses and homing potential of antibody secreting cells (ASC) and T cells depending on cell numbers. Twenty-eight healthy adult volunteers, 18-40 years of age and from the Baltimore community, will be recruited to participate in this study, which will be conducted at the Center for Vaccine Development (CVD), University of Maryland School of Medicine. The volunteers will be randomized to receive either 5x10^9 colony forming units of CVD 909 with buffer or buffer placebo alone. Three weeks later, all volunteers will receive 25 micrograms (0.5 ml) of licensed purified Vi polysaccharide vaccine by the intramuscular route. Blood for serum and antibody secreting cell responses to Vi, S. Typhi LPS, and O antigen will be drawn before and after the Vi boost. The patient participation duration is up to 63 weeks, with the option for prolonged immunologic follow-up for 4 additional years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CVD 909, Biological: Vi Polysaccharide14 subjects Oral CVD 909 with buffer on Day 0. Parental Vi polysaccharide vaccine on Day 21. |
| 2 | Placebo comparator | Drug: Placebo, Biological: Vi Polysaccharide14 subjects oral buffer placebo. Parental Vi polysaccharide vaccine on Day 21. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 - 40 years, inclusive.
- Good general health as determined by a screening evaluation within 30 days before administration of CVD 909 or placebo.
- Expressed interest and availability to fulfill the study requirements.
- Informed, written consent.
- Agrees not to participate in another investigational vaccine or drug trial for the first 84 days of this study.
Key exclusion criteria (51 listed)
- History of any of the following medical illnesses:
- Gall bladder disease or gall stones without cholecystectomy
- Diabetes
- Cancer
- Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
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 |
|---|---|---|
| CVD 9095 X 10^9 CFU of oral S. Typhi vaccine strain CVD 909 with buffer administered on Day 0. | Biological | 1 |
| PlaceboBuffer placebo administered on Day 0. | Drug | 2 |
| Vi Polysaccharide25 micrograms (0.5 ml) of licensed purified Vi polysaccharide vaccine on Day 21. | Biological | 1, 2 |
Primary outcome
Safety: determined by symptom diaries, interim medical histories obtained by interview, by blood and stool cultures, and by clinical laboratory tests.
Time frame: During the 1st 14 days after ingestion of CVD 909 vaccine or placebo, during the 3 days after receiving parenteral Typhim Vi vaccine at Day 24, and interim medical history for safety at Day 42.
4 secondary outcomes
Immunogenicity: assessed by specific antibody secreting cell assays.
Time frame: Days 0 and 10 after oral administration of CVD 909 and Days 0 and 7 after administration of parenteral Vi.
The timing of development and longevity of serum anti-Vi antibodies.
Time frame: Days 0 and 10 after oral administration of CVD 909 and Days 0 and 7 after administration of parenteral Vi.
The subclasses and avidity of antibodies developed.
Time frame: Days 0 and 10 after oral administration of CVD 909 and Days 0 and 7 after administration of parenteral Vi.
Seroconversion rate and titer of serum IgG anti-Vi antibodies.
Time frame: Days 0, 10, 14+/-2, 21+/-2, 28+/-2, 35+/-2, 42+/-2, and 84+/-7 and at 29+/-2 weeks and 55+/- 4 weeks, and every 6 months for 4 years for volunteers who remain seropositive at week 55 and agree to continue participation in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Background: PubMed 24429069Wahid R, Zafar SJ, McArthur MA, Pasetti MF, Levine MM, Sztein MB. Live oral Salmonella enterica serovar Typhi vaccines Ty21a and CVD 909 induce opsonophagocytic functional antibodies in humans that cross-react with S. Paratyphi A and S. Paratyphi B. Clin Vaccine Immunol. 2014 Mar;21(3):427-34. doi: 10.1128/CVI.00786-13. Epub 2014 Jan 15.
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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 1 study testing CVD 909 and Vi Polysaccharide in people with Typhoid Fever, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 6 inclusion and 51 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 9 May 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: determined by symptom diaries, interim medical histories obtained by interview, by blood and stool cultures, and by clinical laboratory tests. (time frame: During the 1st 14 days after ingestion of CVD 909 vaccine or placebo, during the 3 days after receiving parenteral Typhim Vi vaccine at Day 24, and interim medical history for safety at Day 42.). 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 NCT00326443, 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 9 May 2014.