CVD 909 Vi Prime Boost Study

NCT00326443 | Completed Phase 1

• 2 other identifiers: 05-0009Typhoid CVD 36000
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Typhoid Fever

Keywords

Salmonella, vaccine, typhoid fever, S. Typhi

Outcome Measures

Primary Outcomes (1)

• Safety: determined by symptom diaries, interim medical histories obtained by interview, by blood and stool cultures, and by clinical laboratory tests.

  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.

  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.

  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.

  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.

  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.

Study Arms (2)

1

EXPERIMENTAL

14 subjects Oral CVD 909 with buffer on Day 0. Parental Vi polysaccharide vaccine on Day 21.

Biological: CVD 909; Biological: Vi Polysaccharide

2

PLACEBO COMPARATOR

14 subjects oral buffer placebo. Parental Vi polysaccharide vaccine on Day 21.

Drug: Placebo; Biological: Vi Polysaccharide

Interventions

CVD 909 BIOLOGICAL

5 X 10\^9 CFU of oral S. Typhi vaccine strain CVD 909 with buffer administered on Day 0.

1

Placebo DRUG

Buffer placebo administered on Day 0.

2

Vi Polysaccharide BIOLOGICAL

25 micrograms (0.5 ml) of licensed purified Vi polysaccharide vaccine on Day 21.

1; 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 24429069 BACKGROUND

MeSH Terms

Conditions

Typhoid Fever

Interventions

Polysaccharides

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 12, 2006
• First Posted: May 16, 2006
• Study Start: February 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: August 1, 2008
• Last Updated: May 9, 2014

Record last verified: 2010-02

Locations

US (1)