Rotavirus InfectionPhase 1NCT01764256

A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine

A Phase 1 study testing P2-VP8 subunit rotavirus vaccine in people with Rotavirus Infection, run by PATH at 1 site in United States.

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 study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Rotavirus Infection
What is being tested?: P2-VP8 subunit rotavirus vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Dec 2012to Sep 2013
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A qualified volunteer must be:
Healthy male or female between 18 and 45 (inclusive) years of age at time of enrollment.
Willing and able to give informed consent - must pass test of comprehension with > 70% correct within two attempts.
If female and of childbearing potential, be not breastfeeding and not pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to first injection), planning to avoid pregnancy for at least 4 weeks after the last injection, and willing to use an adequate method of contraception consistently and have repeated pregnancy tests prior to second and third injections.
Willing to comply with study restrictions and study schedule (as evidenced by a signed informed consent form (ICF) and assessment by the Principal Investigator (PI) or designee).
Able and willing to be contacted by telephone or text, and willing for study staff to record telephone voice or text messages as needed.

Who cannot join

A qualified volunteer must not:
Have received an investigational product during the 30 days prior to randomization.
Intend to receive another investigational product during this study.
Have any contraindication to parenteral injections (e.g., history of bleeding disorder).
Have previously received a marketed or investigational rotavirus vaccine.
Have a history of severe local or systemic reaction to any vaccine.

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Have a history of recurrent urticaria of unknown cause.
Have a history of any allergic or infusion reaction that was severe (e.g., anaphylactic or anaphylactoid), generalized (e.g., drug rash, urticaria, angioedema) or that, in the opinion of the PI, significantly increases risk of severe local or systemic reaction to an investigative vaccine.
Have a history of reaction to any vaccine that, in the opinion of the PI, significantly increases risk of severe reaction to an investigative vaccine.
Have received any vaccine within 4 weeks prior to randomization or planned vaccination through Day 84.
Have received any blood product or any immunomodulating agent (e.g., immunoglobulin, interferon, growth factor) within 12 weeks prior to randomization.
Have received immunosuppressive medications (e.g., prolonged use of systemic corticosteroid or cytotoxic agent) within the 24 weeks prior to randomization. Eligible if a short course (≤10 days) of systemic corticosteroid concluded more than 2 weeks prior to randomization, use of inhaled corticosteroid for asthma, and use of topical corticosteroid for a skin condition.
Have a history of any clinically significant (in the opinion of the PI) immunosuppressive or autoimmune condition.
Anticipate need for administration of any blood product, immunosuppressive (e.g., systemic corticosteroid), or immunomodulatory treatment during the study.
Have a history of malignancy, excluding basal cell carcinoma.
Have Diabetes Mellitus Type I or II.
Have a positive test for human immunodeficiency virus 1 (HIV-1), Hepatitis B surface antigen (HBsAg) or (Hepatitis C Antibody Test) anti-HepC.
Have significant abnormalities in screening laboratory test results or clinical assessment as determined by the PI or by the PI in consultation with the Sponsor's medical officer.*
Have abnormal vital signs deemed clinically relevant by the Principle Investigator (PI).
Evidence of current or recent (within past 12 months) excessive alcohol consumption or drug dependence.
Have any condition of hand, arm or related lymph nodes that may confound post-dose assessments.
Have any condition (medical, psychiatric or behavioral) that, in the opinion of the PI, would increase the volunteer's health risks in study participation or would increase the risk of not achieving the study's objectives

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Immunization Research
Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: A Phase 1 Double Blinded, Randomized, Placebo-controlled Dose Escalation Study to Examine the Safety, Reactogenicity, Tolerability and Immunogenicity of the P2-VP8 Subunit Rotavirus Vaccine in Healthy Adult Volunteers

This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.

Read the detailed description

The trial will be a double-blinded, randomized, placebo-controlled dose-escalation study in which three dose-levels of vaccine will be tested in adults. Cohorts of 16 individuals (12 vaccine recipients and 4 placebo recipients) per dose level will receive three intramuscular injections four weeks apart. The three dose levels of vaccine to test will be 10 microgram (μg), 30 μg and 60 μg.

Conditions: Rotavirus Infection
Being tested: P2-VP8 subunit rotavirus vaccine, placebo
Keywords: rotavirus, vaccine
Medical subject headings: Rotavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

P2-VP8 subunit rotavirus vaccineBiological
P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration.
placeboOther
Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study.

Study groups in NCT01764256
Study group	Role	What they receive
10 μg P2-VP8	Experimental	3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 10 μg of active ingredient. Receives: Biological: P2-VP8 subunit rotavirus vaccine
30 μg P2-VP8	Experimental	3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 30 μg of active ingredient. Receives: Biological: P2-VP8 subunit rotavirus vaccine
60 μg P2-VP8	Experimental	3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 60 μg of active ingredient. Receives: Biological: P2-VP8 subunit rotavirus vaccine
Placebo	Placebo comparator	3 doses of placebo delivered intramuscularly. Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Severity of Adverse Events After Any Vaccination
Adverse events were collected through 28 days following the final study injection and were graded for severity. Unsolicited adverse events were also assessed for relationship to vaccine. A final follow-up contact was attempted 6 months following the final study injection to inquire about new chronic health conditions, serious health events, and hospitalizations.
Measured: 6 months after final vaccination (224 days)
Maximum Local or Systemic Reactogenicity After Any Vaccination
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination.
Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Measured: 7 days after each vaccination (Day 7, 35, 63)
Maximum Local or Systemic Reactogenicity After the First Vaccination
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination.
Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Measured: 7 days post Vaccination #1 on Day 0
Maximum Local or Systemic Reactogenicity After the Second Vaccination
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination.
Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Measured: 7 days post Vaccination #2 on Day 35
Maximum Local or Systemic Reactogenicity After the Third Vaccination
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination.
Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Measured: 7 days post Vaccination #3 on Day 56

Secondary outcomes (4)

Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses
Seroresponse was defined as as a four-fold increase in antibody titers between baseline and 4-weeks post-third injection.
Measured: 4 weeks post 3rd immunization (84 days)
Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG)
Measured from sera taken on Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection).
Measured: Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection)
Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA)
Measured from sera taken on Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection).
Measured: Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection)
Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain
Seroresponse was defined as as a four-fold increase in antibody titers between baseline and 4-weeks post-third injection.
Measured: 4 weeks post 3rd immunization (84 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Sep 2013

First posted9 Jan 2013 (estimated)
Study startDec 2012
Primary completionJun 2013
Study completionSep 2013

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 Rotavirus InfectionStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01764256
Sponsor's protocol ID: VAC 009
Status last verified: Feb 2019
First submitted: 7 Jan 2013
Last updated: 12 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fix AD, Harro C, McNeal M, Dally L, Flores J, Robertson G, Boslego JW, Cryz S. Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults. Vaccine. 2015 Jul 17;33(31):3766-72. doi: 10.1016/j.vaccine.2015.05.024. Epub 2015 Jun 8.
PubMed 26065919

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 Rotavirus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Double Blinded, Randomized, Placebo-controlled Dose Escalation Study to Examine the Safety, Reactogenicity, Tolerability and Immunogenicity of the P2-VP8 Subunit Rotavirus Vaccine in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT01764256
Acronym / sponsor ID: VAC 009
Conditions: Rotavirus Infection
Keywords: rotavirus, vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: PATHUniversity, hospital or other
Study start: Dec 2012
Primary completion: Jun 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 9 Jan 2013 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

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

This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
10 μg P2-VP8	Experimental	Biological: P2-VP8 subunit rotavirus vaccine3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 10 μg of active ingredient.
30 μg P2-VP8	Experimental	Biological: P2-VP8 subunit rotavirus vaccine3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 30 μg of active ingredient.
60 μg P2-VP8	Experimental	Biological: P2-VP8 subunit rotavirus vaccine3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 60 μg of active ingredient.
Placebo	Placebo comparator	Other: placebo3 doses of placebo delivered intramuscularly.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

A qualified volunteer must be:

Key exclusion criteria (22 listed)

A qualified volunteer must not:

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
P2-VP8 subunit rotavirus vaccineP2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration.	Biological	10 μg P2-VP8, 30 μg P2-VP8, 60 μg P2-VP8
placeboSodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study.	Other	Placebo

Primary outcome

Maximum Severity of Adverse Events After Any Vaccination
Time frame: 6 months after final vaccination (224 days)
Adverse events were collected through 28 days following the final study injection and were graded for severity. Unsolicited adverse events were also assessed for relationship to vaccine. A final follow-up contact was attempted 6 months following the final study injection to inquire about new chronic health conditions, serious health events, and hospitalizations.
Maximum Local or Systemic Reactogenicity After Any Vaccination
Time frame: 7 days after each vaccination (Day 7, 35, 63)
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Maximum Local or Systemic Reactogenicity After the First Vaccination
Time frame: 7 days post Vaccination #1 on Day 0
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Maximum Local or Systemic Reactogenicity After the Second Vaccination
Time frame: 7 days post Vaccination #2 on Day 35
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Maximum Local or Systemic Reactogenicity After the Third Vaccination
Time frame: 7 days post Vaccination #3 on Day 56
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.

4 secondary outcomes

Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses
Time frame: 4 weeks post 3rd immunization (84 days)
Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG)
Time frame: Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection)
Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA)
Time frame: Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection)
Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain
Time frame: 4 weeks post 3rd immunization (84 days)

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	12	10
10 μg P2-VP8	12	11
30 μg P2-VP8	12	11
60 μg P2-VP8	12	12

Primary outcome: Maximum Severity of Adverse Events After Any Vaccination

Time frame: 6 months after final vaccination (224 days). Count of participants. Unit: Participants

Measure	10 μg P2-VP8 n = 12	30 μg P2-VP8 n = 12	60 μg P2-VP8 n = 12	Placebo n = 12
Possibly related to vaccine: Mild	1	2	0	2
Possibly related to vaccine: Moderate	0	1	0	0
Possibly related to vaccine: Severe	0	0	0	0
Possibly related to vaccine: None	11	9	12	10
All adverse events: Mild	6	2	6	5
All adverse events: Moderate	3	3	0	1
All adverse events: Severe	0	0	1	0
All adverse events: None	3	7	5	6

10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8 vs Placebo: p = 0.44, Fisher Exact
10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8 vs Placebo: p = 0.7446, Fisher Exact

Primary outcome: Maximum Local or Systemic Reactogenicity After Any Vaccination

Time frame: 7 days after each vaccination (Day 7, 35, 63). Count of participants. Unit: Participants

Measure	Placebo n = 12	10 μg P2-VP8 n = 12	30 μg P2-VP8 n = 12	60 μg P2-VP8 n = 12
All reactogenicity: None	7	3	6	4
All reactogenicity: Mild	3	7	6	6
All reactogenicity: Moderate	2	2	0	2
Local reactogenicity: None	7	4	7	4
Local reactogenicity: Mild	4	7	5	7
Local reactogenicity: Moderate	1	1	0	1
Systemic reactogenicity: None	10	4	9	6
Systemic reactogenicity: Mild	1	7	3	5

Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 0.5694, Fisher Exact
Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 1.0000, Fisher Exact
Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 1.0000, Fisher Exact

Primary outcome: Maximum Local or Systemic Reactogenicity After the First Vaccination

Time frame: 7 days post Vaccination #1 on Day 0. Count of participants. Unit: Participants

Measure	Placebo n = 12	10 μg P2-VP8 n = 12	30 μg P2-VP8 n = 12	60 μg P2-VP8 n = 12
All reactogenicity: None	7	4	8	5
All reactogenicity: Mild	3	8	4	6
All reactogenicity: Moderate	2	0	0	1
Local reactogenicity: None	7	4	8	5
Local reactogenicity: Mild	4	8	4	6
Local reactogenicity: Moderate	1	0	0	1
Systemic reactogenicity: None	11	8	11	7
Systemic reactogenicity: Mild	0	4	1	5

Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 0.6004, Fisher Exact
Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 1, Fisher Exact
Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 1.00, Fisher Exact

Primary outcome: Maximum Local or Systemic Reactogenicity After the Second Vaccination

Time frame: 7 days post Vaccination #2 on Day 35. Count of participants. Unit: Participants

Measure	Placebo n = 11	10 μg P2-VP8 n = 12	30 μg P2-VP8 n = 12	60 μg P2-VP8 n = 12
All reactogenicity: None	10	6	9	8
All reactogenicity: Mild	1	5	3	4
All reactogenicity: Moderate	0	1	0	0
Local reactogenicity: None	11	7	9	8
Local reactogenicity: Mild	0	4	3	4
Local reactogenicity: Moderate	0	1	0	0
Systemic reactogenicity: None	10	9	12	11
Systemic reactogenicity: Mild	1	3	0	1

Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 1.0000, Fisher Exact
Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 1.0000, Fisher Exact
Placebo vs 10 μg P2-VP8 vs 30 μg P2-VP8 vs 60 μg P2-VP8: p = 1.0000, Fisher Exact

Population analysed: 47 subjects received the second vaccination (one less than Analysis Population Description). Subject in the placebo group withdrew Completed vaccination # 1 but withdrew due to moderate pain, tenderness and swelling, before Vaccination 2.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months after final vaccination (224 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 μg P2-VP8	0 of 12 (0%)	9 of 12 (75%)	0 of 12
30 μg P2-VP8	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
60 μg P2-VP8	1 of 12 (8.3%)	7 of 12 (58.3%)	0 of 12
Placebo	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26065919Fix AD, Harro C, McNeal M, Dally L, Flores J, Robertson G, Boslego JW, Cryz S. Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults. Vaccine. 2015 Jul 17;33(31):3766-72. doi: 10.1016/j.vaccine.2015.05.024. Epub 2015 Jun 8.

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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.

Clayton Harro, MD principal investigator

Johns Hopkins Bloomberg School of Hygiene and Public Health

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 P2-VP8 subunit rotavirus vaccine in people with Rotavirus Infection, run by PATH 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 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 12 Mar 2019. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2019). 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?

Maximum Severity of Adverse Events After Any Vaccination (time frame: 6 months after final vaccination (224 days)). The study lists 5 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 NCT01764256, 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 12 Mar 2019.