Clinical trial NCT04087460: Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine
Official title: A Phase Ⅰa Randomized,Double-Blind, Placebo-controlled Clinical Trial to Preliminary Evaluate the Safety and Immunogenicity of Protein Based Pneumococcal Vaccine（PBPV） in Healthy People Aged Between 18 and 49 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pneumonia
Respiratory Tract Diseases
Respiratory Tract Infections
Keywords: Vaccnie
PspA
Pneomolysin
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Henan Center for Disease Control and Prevention
First posted: 2019-09-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Infections with Streptococcus pneumoniae often cause serious health problems, especially for infants and the elderly.Failure to cover all polysaccharide types is an even greater problem with adults than with children.

The aim of the study is to preliminary evaluate the safety and immunogenicity of PBPV vaccine compared to placebo,in order to provide a basis for subsequent clinical trial design.

Detailed description: The polysaccharide vaccine protected 60% of elderly adults who were at risk for pneumococcal infection.However, pneumococci are highly diverse with respect to their capsular types , and the polysaccharide-protein conjugate vaccines will not protect against strains of the many capsular types not included in the vaccine.This experimental vaccine was covered 70% of all pneumococcal types, Subjects will receive three doses of PBPV vaccine on day 0,60 and 120 with different contents of 20μg,50μg,100μg each antigen in 18 to 49 years of age.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged 18 to 49 years old;
* Willing to provide proof of identity;
* Able to understand and sign the informed consent;
* Able and willing comply with the requirements of the protocol

Exclusion Criteria:

* Hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
* Abnormal changes of laboratory measures (with clinical significance);
* Woman is pregnant and lactating (by urine pregnancy test)
* Suffered from pneumonia in the past three years;
* Invasive diseases caused by Streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years;
* Allergic person;
* Any prior administration of blood products in last 3 month;
* Any prior administration of other research medicines in last 1 month;
* Plans to participate in or is participating in any other drug clinical study;
* Any prior administration of attenuated live vaccine in last 14 days;
* Any prior administration of subunit or inactivated vaccines in last 7 days;
* Had fever before vaccination, volunteers with temperature \>37.0℃ on axillary setting;
* According to the investigator's judgment, the volunteers have any otherfactors that make them unfit to participate in the clinical trial

Primary outcomes:
measure: Safety indexes of solicited and unsolicited adverse reactions
timeFrame: within 30 minutes,0-7 days,0-30 days post-vaccination
measure: Safety indexes of lab measures
timeFrame: day 3 and 8 post the first vaccination
measure: Safety indexes of lab measures
timeFrame: day 14 and 30 post each vaccination
Secondary outcomes:
measure: safety indexes of SAE
timeFrame: within 180 days post vaccination
measure: immunogencity indexes of GMC and GMI by ELISA
timeFrame: day 8, 14,30,60 post each vaccination
measure: immunogencity indexes of the seropositivity rates by ELISA
timeFrame: day 8, 14,30,60 post each vaccination
Other outcomes:
measure: immunogencity indexes of GMT and GMI by Opsonophagocytic assay (OPA)
timeFrame: day30,60 post each vaccination
measure: immunogencity indexes of neutralization test
timeFrame: day30,60 post each vaccination
Locations:
city: Shangqiu
country: China
facility: Suixian Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Province Center for Disease Control and Prevention
name: Xia Shengli
role: PRINCIPAL_INVESTIGATOR
References: