Preliminary data from Phase I/II trails evaluating the vaccine reveal 100 percent of participants had a humoral and cellular response, with no serious adverse events reported.
[Credit: Yalcin Sonat/Shutterstock.com]
Preliminary results from trials evaluating Russia’s COVID-19 vaccine, dubbed Sputnik V, reveal the vaccine caused no serious adverse events and elicited a stable humoral and cellular immune response in all participants.
Russia’s sovereign wealth fund (The Russian Direct Investment Fund [RDIF]) and the Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation have published preliminary findings from Phase I/II testing the vaccine in The Lancet.
Further studies are also expected to be presented for publication, including animal trial results in primates, Syrian hamsters and transgenic mice (anticipated in September 2020) and the preliminary results of the ongoing post-registration clinical trials involving 40,000 volunteers (expected in October or November).
Explore innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
17 September 2025 | 10:00 AM BST | FREE Webinar
In this webinar, find out how AI tools such as customised large language models (LLMs), orchestrated services, and human-in-the-loop design can streamline processes, enhance training, and improve efficiencies.
The Sputnik V vaccine uses two different adenovirus vectors – Ad5 and Ad26 – in two separate injections to elicit an immune response to the SARS-CoV-2 spike protein. The use of a different viral vector for the second shot reportedly prevents the immune response elicited by the first vector rejecting the drug in the second injection and neutralising the effect of the vaccine.
Phase I/II trial results for Sputnik V
The Phase I/II trials were open-label and non-randomised, testing a frozen formulation (Gam-COVID-Vac) and a freeze-dried formulation (Gam-COVID-Vac-Lyo) of the vaccine in healthy adults aged 18-60 years. All participants self-isolated as soon as they were registered for the trial and remained in hospital for the first 28 days after they were first vaccinated.
In the Phase I of each trial, participants received one component of the two-part vaccine (four groups of nine participants were given the frozen or freeze-dried rAd26-S or rAd5-S component). In the Phase II, which began at least five days after the Phase I trial began, participants received the full two-part vaccine (they received a prime vaccination with the rAd26-S component on day 0, followed by a booster vaccination with rAd5-S component on day 21.) There were 20 participants each in the frozen and freeze-dried vaccine groups for the Phase II trial.
Both vaccine formulations were safe and well tolerated over the 42-day study period. The most common adverse events included pain at injection site, hyperthermia, headache, asthenia (weakness) and muscle and joint pain. No serious adverse events (Grade 3) were detected within 42 days of vaccination.
All 40 participants in the Phase II trials produced antibodies against the SARS-CoV-2 spike protein, with levels of antibody against the spike protein (geometric mean titres of SARS-CoV-2 receptor binding domain-specific IgG) at 14,703 for the frozen formulation and 11,143 for the freeze-dried formulation on day 42 of the trial.
In addition, neutralising antibody responses occurred in all participants in the Phase II trials by day 42, where they were only found in 61 percent of participants in the Phase I study who received either formulation of rAd26-S only. According to the authors, the level of virus-neutralising antibodies in vaccinated volunteers was approximately 1.5 times higher than that of convalescent COVID-19 patients.
T cell responses occurred in all participants in the Phase II trials within 28 days of vaccination – including formation of T-helper (CD4) cells and T-killer (CD8) cells. The number of T-helper cells increased by 2.5 percent and the number of T-killer cells increased by 1.3 percent after vaccination with the frozen formulation and by 1.3 percent and 1.1 percent, respectively, after vaccination with the freeze-dried formulation.
Kirill Dmitriev, Chief Executive Officer of the Russian Direct Investment Fund, commented: “The publication in The Lancet… confirms the high safety and efficacy of the Russian vaccine Sputnik V and demonstrates the recognition of Russian scientists by the global scientific community. …During a pandemic, it is especially important to use a vaccine platform with proven safety, as Sputnik V does, so as not to leave the world without an effective protection from coronavirus, but also not to risk people’s lives using untested experimental technologies. We are now witnessing a change in the global approach towards the registration of vaccines with the USA, UK, China and other countries following Russia’s path in fast-tracking registration.”
While the adenovirus (or any virus) platform is a good way to quickly develop a vaccine, it is a short-term one. If you need regular boosts every year, you would need a new adenovirus, i.e. a new vaccine, every time. This is not a new problem, in the past a large pharmaceutical company went under because it puts all of its hopes in this type of vaccines.
This website uses cookies to enable, optimise and analyse site operations, as well as to provide personalised content and allow you to connect to social media. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". Please view our Cookie Policy to learn more about the use of cookies on our website.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Cookie
Description
cookielawinfo-checkbox-advertising-targeting
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".
cookielawinfo-checkbox-analytics
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".
cookielawinfo-checkbox-necessary
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".
PHPSESSID
This cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
zmember_logged
This session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.
Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. These cookies do not store any personal information.
Cookie
Description
cf_ob_info
This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving “Always Online” until the cookie expires.
cf_use_ob
This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving “Always Online” until the cookie expires.
free_subscription_only
This session cookie is served by our membership/subscription system and controls which types of content you are able to access.
ls_smartpush
This cookie is set by Litespeed Server and allows the server to store settings to help improve performance of the site.
one_signal_sdk_db
This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status.
YSC
This cookie is set by Youtube and is used to track the views of embedded videos.
Analytics cookies collect information about your use of the content, and in combination with previously collected information, are used to measure, understand, and report on your usage of this website.
Cookie
Description
bcookie
This cookie is set by LinkedIn. The purpose of the cookie is to enable LinkedIn functionalities on the page.
GPS
This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location
lang
This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc
This cookie is set by LinkedIn and used for routing.
lissc
This cookie is set by LinkedIn share Buttons and ad tags.
vuid
We embed videos from our official Vimeo channel. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. This cookie does not track individuals.
wow.anonymousId
This cookie is set by Spotler and tracks an anonymous visitor ID.
wow.schedule
This cookie is set by Spotler and enables it to track the Load Balance Session Queue.
wow.session
This cookie is set by Spotler to track the Internet Information Services (IIS) session state.
wow.utmvalues
This cookie is set by Spotler and stores the UTM values for the session. UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on.
_ga
This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. It stores information anonymously and assign a randomly generated number to identify unique visitors.
_gat
This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites.
_gid
This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form.
Advertising and targeting cookies help us provide our visitors with relevant ads and marketing campaigns.
Cookie
Description
advanced_ads_browser_width
This cookie is set by Advanced Ads and measures the browser width.
advanced_ads_page_impressions
This cookie is set by Advanced Ads and measures the number of previous page impressions.
advanced_ads_pro_server_info
This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. It is used by cache busting in Advanced Ads Pro when the appropriate visitor conditions are used.
advanced_ads_pro_visitor_referrer
This cookie is set by Advanced Ads and sets the referrer URL.
bscookie
This cookie is a browser ID cookie set by LinkedIn share Buttons and ad tags.
IDE
This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
li_sugr
This cookie is set by LinkedIn and is used for tracking.
UserMatchHistory
This cookie is set by Linkedin and is used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
VISITOR_INFO1_LIVE
This cookie is set by YouTube. Used to track the information of the embedded YouTube videos on a website.
While the adenovirus (or any virus) platform is a good way to quickly develop a vaccine, it is a short-term one. If you need regular boosts every year, you would need a new adenovirus, i.e. a new vaccine, every time. This is not a new problem, in the past a large pharmaceutical company went under because it puts all of its hopes in this type of vaccines.