Skip to main content
. 2020 Oct 18;202(2):162–192. doi: 10.1111/cei.13517

Table 3.

Data from Published Phase I studies. Data from peer‐reviewed journals or pre‐prints. Data published on company websites not included

Vaccine manufacturer Safety Immunogenicity Reference
University of Oxford/AstraZeneca

Mild/Moderate injection site pain

Mild‐Severe systemic adverse reactions including chills, fatigue, malaise and headache, peaking day one, reduced by paracetamol.

Seroconversion with neutralising antibodies, (91% after one dose, 100% after two doses).

IFNγ ELISPOT responses detected,.

[165]
Wuhan Institute of Biological Products/Sinopharm

Local reactions in 25% of highest dose (Phase I)

Adverse reactions in 6‐19% (Phase II)

Phase I: 95‐100% seroconversion (ELISA and neutralisation).

Phase II: 85‐100% seroconversion

[149]
BioNTech/Pfizer

Dose 1: Local reactions in 100% of 30µg (mild‐moderate) and 100µg groups (mild‐severe)

Systemic reactions in up to 80% of 100µg (mild‐severe).

Dose 2: systemic reactions in 100% of 30µg group (mild‐severe)

Similar results seen in second study with same construct (BNT162b1)

Comparative study with alternate construct (BNT162b2) showed lower reactogenicity

Seroconversion with neutralising antibodies and ELISA binding

Higher response in higher dose group

Neutralising antibody increased on booster in 10µg and 30µg groups.

Similar results seen in second study with same construct

Comparative study with alternative construct had equivalent immunogenicity

[198, 199, 200]
CanSino Biological Inc./Beijing Institute of Biotechnology

Phase I: Local reactions in 54% (mild or moderate)

Systemic adverse events in 46 % (mild‐severe)

No effect of dose size on effects.

Phase II: Adverse reactions in 72%, more severe events in larger dose group (9%). Including injection site pain (56%) and fever (32% in high dose)

Adverse effects lower in individuals with pre‐existing anti‐Ad5 antibodies

Phase I: Seroconversion (ELISA binding) 44‐61% after 1 dose, 97‐100% after 2 doses.

Seroconversion (Neutralising) 28‐42% after 1 dose, 50‐75% after 2 doses.

IFNγ ELISPOT responses detected.

Phase II: Seroconversion (Neutralising) 59‐61% after 2 doses.

IFNγ ELISPOT responses detected after 2 doses.

[166, 167]
Moderna/NIAID

Systemic adverse events – mild/moderate after first dose, increasing with µg RNA administered.

More adverse effects on second dose. All of 250 µg group reported systemic adverse effects after second dose, 21% were severe.

100% seroconversion by after second dose by ELISA and neutralisation.

Increase in response from 25 µg to 100µg dose, rough equivalence between 100µg and 250µg dose.

Antigen specific T cells detectable, greater in 100µg group than 25µg.

[196]
Sinovac Low rate of adverse effects – no different to placebo

90% seroconversion reported by ELISA and neutralisation

Slight reduction in titre in older groups.

[148]
Gamaleya Research Institute

Mild‐moderate systemic adverse effects (mild fever in 95% of volunteers) for liquid formulation, less for lyophilised.

Mild local adverse effects (injection site pain)

100% seroconversion reported by ELISA and neutralisation.

Anti‐vector antibodies observed but did not correlate with sero‐conversion or anti‐RBD titre.

Antigen specific IFNγ T ELISPOT responses.

[171]
Novavax

Mostly mild systemic adverse effects, some moderate‐severe, increased severity on second dose; headache and fatigue most common.

Mild‐moderate local adverse effects (Tenderness and site pain).

Increased adverse effects with adjuvant.

100% seroconversion by ELISA in groups with adjuvant, no difference in antibody response between high (25µg) and low (5µg) groups. Boosting effect observed by 2 shots. Neutralisation titres much greater in adjuvanted groups, but only 100% after boost.

Subset had T cell responses analysed.

[128]